胃鏡室DndoscopcLaboratory

神經內科NeurologyDepartment

腫瘤夕卜科OncologicalSurgery

SCT室SC(Laboratory

人工腎室HemodialysesRoom

介入科InvasiveTechnologyDepartment

神經外科NeurologicalSurgery

超聲診斷科UltrasonicDiagnosisDeparment

DSA室DSARoom

呼吸科PncumologyDepartment

骨科OrthopedicsDepartment

超聲多譜勒室UltrasonicDopplerLaboratory

血液凈化室LaminarAirflow(LAF)Room

腎內科UrologyDepartment

小兒外科PediatricSurgery

核醫學科IsotopicLaboratory

高壓氧倉室HyperbaricChamber

小兒科PediatricsDepartment

整形科PlasticSurgei-y

ECT室ECTLaboratory

院內感染監控室NosocomialInfectionMonitory

中醫科TraditionalChineseMedicineDepartment

燒傷科DepartmentofBurn

供應室SupplyHouse

血液成份別離室CytopheresisLaboratory

高干病房SeniorOfficialsinpatientWard

UrineAnalyzer尿液分析儀

bloodsugar(glucose)analyzer血糖分析儀

teststrip測試條

reagent試劑

Semi-automaticBiochemicalAnalyzer半自動生化分析儀

AutomaticBloodCellAnalyzer全自動血細胞分析儀

Urinesedimentsanalyzer尿沉渣

Bio-safetyCabinet生物平安柜

Incubator培育箱

HighFrequencyElectrotome高頻電刀

shadowlesslamp無影燈

Highspeedrefrigeratedcentrifuge高速冷凍離心機

hotairsterilizer熱空氣消毒箱

microbiologicalincubator微生物培育箱

Halogenlight鹵素燈

disposablesterileinjector一次性無菌注射針

injectionset注射器

disposablevenousinfusionneedle一次性靜脈輸液針

disposableinfusionset一次性運用輸液器

bloodtransfusionset輸血.港

infusionbag液袋

urinedrainagebag集尿袋

bloodbag血袋

medicalcatheter醫用導管

stainlesssteelneedle不銹鋼醫用針管

bloodtakingneedle采血針

needledestroyer針頭銷毀器

automaticpacker自動紙塑包裝機

scalpveinset頭皮針

uniprocessorversion單機版

networkversion網絡版

macromolecule-solvent高分子溶解的

macromoleculecoldaccumulation高分子蓄冷

coldtreatment冷療法

iccpack冰袋

eyeshade眼罩

Medicalinjectionpump醫用灌注泵

lithotrite碎石機

extracorporealshockwavelithotrite體外沖擊碎石機

Ballisticintracroporeallithotrite氣壓沖擊體內碎石機

Laparoscope腹腔鏡

Urology泌尿外科

kidneyslones腎結石

Multi-parametermonitor,多參數監護儀

maternalmonitor/felalmonitor母親/胎兒監護儀

ICUmonitor重癥監護儀

anestheticequipment麻醉機

respirator呼吸機

electroniccolposcope電子陰道鏡

smogabsorber煙霧汲取器

digitalfilmroom數字膠片室

PermanentMagnetOpenMagneticResonancesystem永磁開放式磁共振系統

UltrasonicColorDopplerDiagnosticsystem彩色超聲多普勒診斷系統

MobileCTsystem移動CT系統

X-rayMammaryMachine乳腺X線機

Mammography乳腺

highprecisionStereotaxic圖精度腦立體定向儀

portableType-Bultrasonic更攜式B超

SterilizationandDisinfectionEquipment消毒滅菌設備

Radiotherapeuticequipment.放射療法設備

pharmaceuticalequipments.?1］藥設備

horizontalpressurizedsteamsterilizer一般臥式壓力蒸汽滅菌器

medicalelectroniclinearaccelerator醫用電子直線加速器

highfrequencyX-raysdiagnosticmachine高頻X射線診斷機

simulatedpositioner模擬定位機

highfrequencymobileX-raysmachine高頻移動X射線機

聯邦食品、藥品和扮裝品法(FederalFood,Drug,andCosmeticAct,EDCA)第510(k)節的豁免限制

Limitationsofexemptionsfromsection510(k)oftheFederalFood,Drug,andCosmeticAct(the

act)

B亞部---心血管診斷器械(CardiovascularDiagnosticDevices)

心律失常探測器和警報器(包括ST段測量和警報)

Arrhythmiadetectorandalarm(includingST-segmentmeasurementandalarm)

血壓警報器

Bloodpressurealarm

血壓計算機

Bloodpressurecomputer

870.1120

血壓袖帶

B1oodpressurecuff

非侵入式血壓測量系統

Noninvasivebloodpressuremeasurementsystem

靜脈血壓計

Venousbloodpressuremanometer

診斷用血管內導管

Diagnosticintravascularcatheter

連續式沖洗導管

Continuousflushcatheter

電極記錄導管或電極記錄探針

Electroderecordingcatheterorelectroderecordingprobe

光纖式血氧計導管

Fiberopticoximetercatheter

導流導管

Flow-directedcatheter

經皮導管

Percutaneouscatheter

腔內心音導管系統

Intracavitaryphonocathetersystem

可操縱導管

Steerablecatheter

可操縱導管限制系統

Steerablecathetercontrolsystem

導管套管

Cathetercannula

經皮插入導管用的血管擴張器

Vesseldilatorforpercutaneouscatheterization

導管導線

Catheterguidewire

導管插入器

Catheterintroducer

導管球囊修理工具盒

Catheterba11oonrepairkit

示蹤微球體

Tracemicrosphere

導管尖端封閉器

Cathetertipoccluder

導管探針

Catheterstylet

套管針

Trocar

可編程的診斷用計算機

Programmablediagnosticcomputer

預編程的單功能診斷用計算機

Single-function,preprogrammeddiagnosticcomputer

光密度計

Densitometer

血管造影注射器和注射管

Angiographicinjectorandsyringe

指示劑注射器

Indicatorinjector

注射器的注射管制動器

Syringeactuatorforaninjector

體外可編程起搏器脈沖發生器

Externalprogrammablepacemakerpulsegenerator

抽縮式輸液泵

Withdrawal-infusionpump

聽診器

Stethoscope

熱稀新探頭

Thermodilutionprobe

C亞部,---心血管監測器械(CardiovascularMonitoringDevices)

生物電位放大器和信號調整器

Biopotentialamplifierandsignalconditioner

傳感器信號放大器和調整器

Transducersignalamplifierandconditioner

心血管血液流量計

Cardiovascularb1oodflowmeter

血管外血流探頭

Extravascularbloodflowprobe

監測器(包括心率計和心率警報器)

Cardiacmonitor(includingcardiotachometerandratealarm)

尖端心動描記器(心振動圖儀)

Apexcardiograph(vibrocardiograph)

心沖擊描記器

Bal1istocardiograph

超聲波心動圖儀

Echocardiograph

心電圖儀

Electrocardiograph

心電圖儀導線轉換接合器

Electrocardiographleadswitchingadaptor

心電圖儀電極

Electrocardiographelectrode

心電圖儀外表電極檢測器

Electrocardiographsurfaceelectrodetester

心音圖儀

Phonocardiograph

心電向量圖儀

Vectorcardiograph

醫用陰極射線管顯示器

Medicalcathode-raytubedisplay

信號隔離系統

Signalisolationsystem

在線隔離監視器

Lineisolationmonitor

便攜式漏電流警報器

Portableleakagecurrentalarm

動脈搏動描記器

Oscillometer

光電血氧計

Oximeter

耳光電血氧計

Earoximeter

阻抗式靜脈搏動描記器

Impedancephlebograph

阻抗式體積描記器

Impedanceplethysmograph

水壓式、氣動式或光電式體積描記器

Hydraulic,pneumatic,orphotoelectricplethysmographs

醫用磁帶記錄器

Medicalmagnetictaperecorder

紙質圖表記錄器

Paperchartrecorder

尖端心動描記傳感器

Apexcardiographictransducer

血管外血壓傳感器

Extravascularbloodpressuretransducer

心音傳感器

Heartsoundtransducer

導管頂端壓力傳感器

Cathetertippressuretransducer

超聲式傳感器

Ultrasonictransducer

脈管閉塞傳感器

Vesselocclusiontransducer

患者傳感器和電極電纜(包括連接器)

Patienttransducerandelectrodecable(includingconnector)

射頻生理信號發送器和接收器

Radiofrequencyphysiologicalsignaltransmitterandreceiver

式心電圖儀發送器和接收器

Telephoneelectrocardiographtransmittcrandreceiver

D亞部---心血管修復器械(CardiovascularProstheticDevices)醫療曙械之窗

血管夾

Vascularclip

腔靜脈夾

Venacavaclip

動脈栓塞隅械

Arterialembolizationdevice

心血管內過濾器

Cardiovascularintravascularfilter

血管移植假體

Vasculargraftprosthesis

聚丙烯、聚對苯二中酸乙酯或聚四氟乙烯制成的心內補片或紗布

Intracardiacpatchorpledgetmadeofpolypropylene,polyethyleneterephthalate,or

polytetrafluoroethylene

大動脈內球囊和限制系統

Intra-aorticballoonandcontrolsystem

心室旁路(協助)器械

Ventricularbypass(assist)device

體外起搏器脈沖發生新

Externalpacemakerpulsegenerator

植入式起搏器脈沖發生器

Implantablepacemakerpulsegenerator

起搏器導線接合器

Pacemakerleadadaptor

起搏器發生器功能分析儀

Pacemakergeneratorfunctionanalyzer

間接式起搏器發生器功能分析儀

Indirectpacemakergeneratorfunctionanalyzer

起搏器聚合體網袋

Pacemakerpolymericmeshbag

起搏器充電器

Pacemakercharger

心血管永久性或臨時性起搏器電極

Cardiovascularpermanentortemporarypacemakerelectrode

起搏器測試磁鐵

Pacemakertestmagnet

起搏器程序器

Pacemakerprogrammers

起搏器修第或替換材料

Pacemakerrepairorreplacementmaterial

起搏器電極功能檢測器

Pacemakerelectrodefunctiontester

起搏器修理工具

Pacemakerservicetools

腑環成形術環

Annuloplastyring

頸動脈竇神經刺激器

Carotidsinusnervestimulator

心臟瓣膜替代品

Replacementheartvalve

心臟瓣膜假體支架

Prostheticheartvalveholder

心臟簫膜假體篩選器

Prostheticheartvalvesizer

E亞部---心血管手術器械(CardiovascularSurgicalDevices)

心肌膜炎活組織檢查罌械

Endomyocardialbiopsydevice

心肺旁路附屬設備

Cardiopulmonarybypassaccessoryequipment

心肺旁路氣泡探測器

Cardiopulmonarybypassbubbledetector

心肺旁路血管導管、套管或管路

Cardiopulmonarybypassvascularcatheter,cannula,ortubing

心肺旁路心肺機限制臺

Cardiopulmonarybypassheart-lungmachineconsole

心肺旁路消泡器

Cardiopulmonarybypassdefoamer

心肺旁路熱交換器

Cardiopulmonarybypassheatexchanger

心肺旁路溫度限制器

Cardiopulmonarybypasstemperaturecontroller

心肺旁路動脈血過濾器

Cardiopulmonarybypassarteriallinebloodfilter

心肺旁路心切開術抽吸管路血液過濾器

Cardiopulmonarybypasscardiotomysuctionlinebloodfilter

心肺旁路前過濾器

Cardiopulmonaryprebypassfilter

心肺旁路接合器、旋塞閥、匯流管或配件

Cardiopulmonarybypassad叩tor,stopcock,manifold,orfitting

心肺旁路氣體限制裝苴

Cardiopulmonarybypassgascontrolunit

心肺旁路冠狀動脈壓力計

Cardiopulmonarybypasscoronarypressuregauge

心肺旁路脈動流發生及

Cardiopulmonarybypasspulsatilef1owgenerator

心肺旁路即時血氣監測儀

Cardiopulmonarybypasson-linebloodgasmonitor

心肺旁路液面自動檢測監視器和/或限制器

Cardiopulmonary