Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- K234003The Circadia C200 System2Cleared 510(K)
- K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software2Cleared 510(K)
- K231733Neteera 130H-Plus Vital Sign Monitoring Sensor2Cleared 510(K)
- K223163Sleepiz One+2Cleared 510(K)
- K212143Neteera 130H/131H Vital Sign Monitoring Sensor2Cleared 510(K)
- K202138Cardiac Trigger Monitor2Cleared 510(K)
- K202464Vital Sign Monitoring Sensor (Model :XK300)2Cleared 510(K)
- K181165Philips wearable biosensor-G5 Solution2Cleared 510(K)
- K172586Vios Monitoring System™ Model 20502Cleared 510(K)
- K170828Cardiac Trigger Monitor2Cleared 510(K)
- K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor2Cleared 510(K)
- K150992Vios Monitoring System2Cleared 510(K)
- K121860ESA6152Cleared 510(K)
- K121722ESA620 ELECTRICAL SAFETY ANALYZER2Cleared 510(K)
- K110429PROSIM 4, PROSIM 6, PROSIM 82Cleared 510(K)
- K110987CARDIAC TRIGGER MONITOR2Cleared 510(K)
- K103336MPS450 MULTIPARAMETER SIMULATOR2Cleared 510(K)
- K092809HRV ACQUIRE2Cleared 510(K)
- K102174ZOLL PROPAQ M2Cleared 510(K)
- K100745LIFEBED NETWORK PATIENT VIGILANCE SYSTEM2Cleared 510(K)
- K092037LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM2Cleared 510(K)
- K091985UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE2Cleared 510(K)
- K091050506CN PATIENT MONITOR2Cleared 510(K)
- K083534LIFEBED NETWORK PATIENT VIGILANCE SYSTEM2Cleared 510(K)
- K083854CARDIAC TRIGGER, MODEL: CTM3002Cleared 510(K)
- K082626PAM 30002Cleared 510(K)
- K082366LIFEBED PATIENT VIGILANCE SYSTEM2Cleared 510(K)
- K063735PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 1122Cleared 510(K)
- K06030712 RL ALGORITHM2Cleared 510(K)
- K052446LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM2Cleared 510(K)
- K051038506 PATIENT MONITOR2Cleared 510(K)
- K033646TRIFIT 7002Cleared 510(K)
- K043517TRANSMITTER, ZS-940PA SERIES2Cleared 510(K)
- K043354MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 207012Cleared 510(K)
- K032733PM-8000 PATIENT MONITOR, MODEL 80002Cleared 510(K)
- K030656ENVAN HEART RATE MONITOR2Cleared 510(K)
- K023616PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)2Cleared 510(K)
- K022435507EL VITAL SIGNS MONITOR2Cleared 510(K)
- K021681MICROPAQ, MODELS 402, 4042Cleared 510(K)
- K020144SIEMENS INFINITY SC 6002XL MODIFICATIONS2Cleared 510(K)
- K012763SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM2Cleared 510(K)
- K012451PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 2462Cleared 510(K)
- K010587ACTIVEECG2Cleared 510(K)
- K002061A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR2Cleared 510(K)
- K001775ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM2Cleared 510(K)
- K002725MICROPAQ, MODELS 402 AND 4042Cleared 510(K)
- K992413ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR2Cleared 510(K)
- K992411ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR2Cleared 510(K)
- K984033ATLAS MONITOR2Cleared 510(K)
- K981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP12Cleared 510(K)
- K974581MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT2Cleared 510(K)
- K974178PASSPORT 5L-CE MODEL 0998-00-0131XXX2Cleared 510(K)
- K973918NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES2Cleared 510(K)
- K965158HEART PROTECTOR (VER 1996)2Cleared 510(K)
- K972787ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P2Cleared 510(K)
- K972789ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-00162Cleared 510(K)
- K963576MOBILE MEDICAL MONITOR (M3(A))2Cleared 510(K)
- K952790LOG-A-RYTHM MODEL 100 AND MODEL 10012Cleared 510(K)
- K960544CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM2Cleared 510(K)
- K950688OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM2Cleared 510(K)
- K952474EAGLE 3000 PATIENT MONITOR2Cleared 510(K)
- K941252RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR2Cleared 510(K)
- K944262ECG MONITOR2Cleared 510(K)
- K945071PROPAQ 200 MONITOR2Cleared 510(K)
- K940081MERCURY2Cleared 510(K)
- K943243PULSE HEART RATE MONITOR2Cleared 510(K)
- K943242PRO-SPORT HEART RATE MONITOR2Cleared 510(K)
- K934644K3 SYSTEM2Cleared 510(K)
- K934684PAM CARDIAC MONITOR2Cleared 510(K)
- K944257LIONHEART 3 MULTI-PARAMETER SIMULATOR2Cleared 510(K)
- K936051OMNI-CENTRAL STATION MONITOR2Cleared 510(K)
- K926298520 DISPLAY DRIVER- STATUS I2Cleared 510(K)
- K935817MEDSIM 300 PATIENT SIMULATOR2Cleared 510(K)
- K930004ESCORT 100/300 SERIES B PATIENT MONITORS2Cleared 510(K)
- K911611SYSTEM ATHENA, MODIFICATION2Cleared 510(K)
- K921194HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING2Cleared 510(K)
- K915624MODIFIED BIOLOG2Cleared 510(K)
- K920099GYMMAN2Cleared 510(K)
- K910665MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED2Cleared 510(K)
- K914576KELLER CARDIAC MONITOR MEDIL KMS8702Cleared 510(K)
- K912049SYSTEM ATHENA - PRODUCT ENHANCEMENTS2Cleared 510(K)
- K911598DATASCOPE PASSPORT MONITOR2Cleared 510(K)
- K912008TRU-VIEW MULTI-CHANNEL DISPLAY2Cleared 510(K)
- K910870EDENTEC MODEL 3711 DIGITAL RECORDER2Cleared 510(K)
- K910852507 NON-INVASIVE VITAL SIGNS MONITOR2Cleared 510(K)
- K903512FUTURECARE CARELYNK IV SYSTEM2Cleared 510(K)
- K905274VITALMAX 2100/22002Cleared 510(K)
- K911616HORIZON XL2Cleared 510(K)
- K911139HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A2Cleared 510(K)
- K910882PROPAQ 102EL, 104EL AND 106EL2Cleared 510(K)
- K904696WEP-8430A TELEMETRY CENTRAL STATION2Cleared 510(K)
- K904353CARDIOMATIC MODEL MSC-20012Cleared 510(K)
- K902652MORTARA INSTRUMENT MODEL ELI 502Cleared 510(K)
- K900451VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE2Cleared 510(K)
- K902608CARDIOMATIC MODEL MSC-10012Cleared 510(K)
- K901031PCI MODEL 2041-PC TELEMETRY MONITOR2Cleared 510(K)
- K896700TYPE 9140/NEO2Cleared 510(K)
- K896699TYPE 9040/NEO2Cleared 510(K)
- K901034MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL2Cleared 510(K)
- K900032MODEL M1175A/M1176A WITH ST SEGMENT MONITORING2Cleared 510(K)
- K895801MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM2Cleared 510(K)
- K895534BIOLOG2Cleared 510(K)
- K897080CARDIOCAP(TM) CT-104 MONITOR2Cleared 510(K)
- K885085ERGOMED 840/ERGOMED 840L2Cleared 510(K)
- K894700TYPE PDU/CDU 9040 (SYSTEM ATHENA)2Cleared 510(K)
- K894699TYPE 9140 (SYSTEM ATHENA)2Cleared 510(K)
- K893405MODEL DS-504 DYNASCOPE PATIENT MONITOR2Cleared 510(K)
- K894919NR5000 E.C.G. AND PULSE OXIMETER MONITOR2Cleared 510(K)
- K892795PULSE TIME PRODUCTS LIMITED, PM-32Cleared 510(K)
- K892794PULSE TIME PRODUCTS LIMITED, PM-22Cleared 510(K)
- K892066HORIZON CENTRAL STATION2Cleared 510(K)
- K890876BP-8800 BLOOD PRESSURE MONITOR2Cleared 510(K)
- K892006HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S2Cleared 510(K)
- K884804THE COACH2Cleared 510(K)
- K884117TYPE 9210 ECG SYSTEM ATHENA2Cleared 510(K)
- K884455MODEL 702 ECG/RESPIRATION/TEMPERATURE2Cleared 510(K)
- K884096PATIENT MONITOR MODEL 7012Cleared 510(K)
- K884645PATIENT MONITOR RIGEL MODEL MULTICARE 4292Cleared 510(K)
- K882609MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM2Cleared 510(K)
- K883109MINIMON 7136B PATIENT MONITOR2Cleared 510(K)
- K883069MINIMON 7134B PATIENT MONITOR2Cleared 510(K)
- K884320PROPAQ 106(TM)2Cleared 510(K)
- K875160RIGEL MODEL MULTICARE 4092Cleared 510(K)
- K874148MONITRON SYSTEM2Cleared 510(K)
- K880498RM-301 PATIENT MONITOR2Cleared 510(K)
- K880066MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR2Cleared 510(K)
- K874319MONITOR, ELECTROGRAPHIC2Cleared 510(K)
- K874844CARE TELSTAT MODELS: MP 5010 AND MP 50202Cleared 510(K)
- K874695HEALTHDYNE APNEA/HEART MONITOR, MODEL 9002Cleared 510(K)
- K872443COMPANION 50 REGULATOR/FLOWMETER2Cleared 510(K)
- K872354SERIES 2000 BEDSIDE PATIENT MONITOR2Cleared 510(K)
- K872249SIRECUST MODEL 960 AND 961 PATIENT MONITORING2Cleared 510(K)
- K871149DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER2Cleared 510(K)
- K864748PM-8 HEART RATE MONITOR2Cleared 510(K)
- K863494NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 202Cleared 510(K)
- K863466M700 STRESS MONITOR2Cleared 510(K)
- K862463LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC2Cleared 510(K)
- K850449DIGITAL PULSE METER HRM-100E & ETC.2Cleared 510(K)
- K863534LIFE-WATCH MONITOR LT-82Cleared 510(K)
- K861621CARDIAN II CR45A2Cleared 510(K)
- K854847PHYSIO-DYNE ECG/HR 32Cleared 510(K)
- K854492ERG 551 ERGOMETER, BICYCLE2Cleared 510(K)
- K854493ERG 555 COUCH ERGOMETER2Cleared 510(K)
- K854491ERG 550 ERGOMETER BICYCLE2Cleared 510(K)
- K853953CARDIOCAP MONITOR2Cleared 510(K)
- K854597VICKERS MEDICAL MODEL 271 HEART RATE MONITOR2Cleared 510(K)
- K854639BIOMECCA CENTRAL CS12Cleared 510(K)
- K855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM2Cleared 510(K)
- K854198PE-3000 PULSE RATE MONITOR2Cleared 510(K)
- K854881SIRECUST 341 AND 341R2Cleared 510(K)
- K853318PATIENT MONITOR PB2402Cleared 510(K)
- K853757MOLDTEC STIMULATOR2Cleared 510(K)
- K854041CD-100 CARDIAC MONITOR2Cleared 510(K)
- K853673CARDIORATER CR 512Cleared 510(K)
- K852910CARDIORATER CR72Cleared 510(K)
- K852887CR5 CARDIAC MONITOR2Cleared 510(K)
- K851916VSM MODELS A & B2Cleared 510(K)
- K840717ECS 5022Cleared 510(K)
- K851335COACH TM- THE AEROBIC FITNESS MONITOR2Cleared 510(K)
- K843533CARDIAC EVENT RECORDER2Cleared 510(K)
- K850619BEDSIDE PATIENT MONITOR W/MODULES2Cleared 510(K)
- K842817MODEL 78353B2Cleared 510(K)
- K851325MICROCOR ECG MONITOR2Cleared 510(K)
- K850135MEDWATCH 400 CARDIAC CENTRAL NURSES STATION2Cleared 510(K)
- K844731KONTRON SUPERMON 7210 PATIENT MONITOR2Cleared 510(K)
- K850880HORIZON 1000 CARDIAC MONITOR2Cleared 510(K)
- K850407NEONATAL MONITOR 3092Cleared 510(K)
- K844187SIEMENS SIRECUST 404N NEONATAL MONITOR2Cleared 510(K)
- K844215KONTRON MINIMON 7134 PATIENT MONITOR2Cleared 510(K)
- K844732KONTRON MINIMON 7132 PATIENT MONITOR2Cleared 510(K)
- K844733KONTRON MINIMON 7131 PATIENT MONITOR2Cleared 510(K)
- K850156ECG PATIENT MONITOR 3012Cleared 510(K)
- K850155ECG PATIENT MONITOR 3022Cleared 510(K)
- K842037LS 52Cleared 510(K)
- K850114C/PES 9201, ECG STRESS TESTING SYS2Cleared 510(K)
- K850113C/PES 9103, ECG STRESS TESTING SYSTEM2Cleared 510(K)
- K850043CARDIOGUARD STRESS TEST MONITOR 40022Cleared 510(K)
- K844888SPACELABS SERIES 600 PATIENT MONITORS2Cleared 510(K)
- K844911ARRHYTHMIA CENTRAL-OGP-72012Cleared 510(K)
- K842236PATIENT MONITOR 78354A2Cleared 510(K)
- K843376ECG PATIENT MONITOR2Cleared 510(K)
- K842582CARE 5000 CENTRAL MONITOR MS5220 ETC.2Cleared 510(K)
- K844348DYNASCOPE MONITOR DS-8002Cleared 510(K)
- K840523SERVOMED PULSE AMPLIFIER MODULE-206-2Cleared 510(K)
- K840524SERVOMED BASIC BEDSIDE UNIT SMV 110TP2Cleared 510(K)
- K833689DIASCOPE 22Cleared 510(K)
- K841363HEART RATE/RESPIRATION SIMULATOR 83102Cleared 510(K)
- K840832SERVOMED OXCARDIORE SPIROGRAPH 324/1112Cleared 510(K)
- K842462HOLTER SCREENING MONITOR HS-2212Cleared 510(K)
- K833594FUKUDA DENSHI FX-302 AUTO/THREE CHAN2Cleared 510(K)
- K841499LIFESCOPE II2Cleared 510(K)
- K841502LIFESCOPE 6 OEC-61052Cleared 510(K)
- K841501LIFESCOPE 6 OEC-61022Cleared 510(K)
- K840055DYNASCOPE SERIES2Cleared 510(K)
- K842321AIR SHIELDS AS461 MONITORING SYS2Cleared 510(K)
- K840525SERVOMED COMPACT MONITOR SMK 155-1/1012Cleared 510(K)
- K840521SERVOMED DIGITAL DISPLAY MODULE2Cleared 510(K)
- K834600RECOMB ECG PREAMPLIFIER/206 069 032Cleared 510(K)
- K834530EXTENSION BOX EB2002Cleared 510(K)
- K832250SERVOMED BASIC BEDSIDE UNIT SMA 102-2Cleared 510(K)
- K840560NEONATAL PHYSIOLOGICAL MONITOR 9032Cleared 510(K)
- K832095SEVOMED COMPACT MONITOR SMK 154-2Cleared 510(K)
- K832025SERVOMED COMPACT MONITOR SMK 155-7/1012Cleared 510(K)
- K840251PATIENT MONITOR 78534B2Cleared 510(K)
- K833552TREND PROCESSOR OPTION FOR #515 NEONAT2Cleared 510(K)
- K832724ACTIMETER UB-1032Cleared 510(K)
- K831164PATIENT MONITOR CM 1352Cleared 510(K)
- K832131SERVOMED CENTRAL STATION SMV 2062Cleared 510(K)
- K832035SERVOMED COMPACT MONITOR SMK 155-92Cleared 510(K)
- K832021SERVOMED COMPACT MONITOR SMK 154-8/1012Cleared 510(K)
- K832018SERVOMED COMPACT MONITOR 181/101050022Cleared 510(K)
- K831818CENTRAL STATION MONITOR CSM-1002Cleared 510(K)
- K831817PATIENT MONITOR #RM-1002Cleared 510(K)
- K832041SERVOMED STANDARD SMS 1042Cleared 510(K)
- K832026SERVOMED BASIC BEDSIDE UNIT SMS 108 W/2Cleared 510(K)
- K832024SERVOMED BASIC BEDSIDE UNIT - VARIOUS2Cleared 510(K)
- K832016LME HEART-RATE MONITOR2Cleared 510(K)
- K831944PATIENT MONITOR #78832A2Cleared 510(K)
- K831943PATIENT MONITOR 788 33A2Cleared 510(K)
- K831428AS 1740 INTERFACE MODULE2Cleared 510(K)
- K831787PATIENT MONITOR #78353A2Cleared 510(K)
- K831752BIOCHECK PEC-108 PROGRAM-PULSE MONITOR2Cleared 510(K)
- K831430AIR SHIELDS AS-100 MONIORING SYS-AS1052Cleared 510(K)
- K831578PHYSIOLOGICAL MONITOR #9022Cleared 510(K)
- K830916VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR2Cleared 510(K)
- K830885GOULD MODEL IM3000-IM3100 BATTERY POWER2Cleared 510(K)
- K830517CENTRAL STATION DISPLAY/RECORDER MATRIX2Cleared 510(K)
- K830587VITAL SIGNS MONITOR 22Cleared 510(K)
- K823904MODEL 515 NEO-TRAK NEONATAL MONITOR2Cleared 510(K)
- K830795CABINET FOR MULTIPLE FUNCTION BLOCKS2Cleared 510(K)
- K830779PRESSURE FUNCTION BLOCK FOR BLOOD PRESS2Cleared 510(K)
- K830282ELECTRONIC EXERCISE #313-PULSE RATE2Cleared 510(K)
- K830433PATIENT MONITOR 5752Cleared 510(K)
- K830432CENTRAL STATION 5902Cleared 510(K)
- K823290NEUROMEDICS PACETRON HEART RATE MONITOR2Cleared 510(K)
- K823197MODEL 8300 TESTER2Cleared 510(K)
- K823312CADIO-RESPIRATORY MONITOR #CR-22Cleared 510(K)
- K8229525602Cleared 510(K)
- K822876MODEL 78534A PATIENT MONITOR2Cleared 510(K)
- K822692DIGITAL PULSE METER (73 BWS) #HRM-100E2Cleared 510(K)
- K822695SIGNAL DISTRIBUTION NETWORK #78581A2Cleared 510(K)
- K822615LIFE WATCH LSI2Cleared 510(K)
- K822390LIFE TRACE 242Cleared 510(K)
- K822389LIFE TRACE 40/422Cleared 510(K)
- K822319RE1000 HEART RATE MONITOR2Cleared 510(K)
- K822388LIFE TRACE 142Cleared 510(K)
- K821942HARVEY-BOSTWICK BRADY CARDIA MONIT. HB852Cleared 510(K)
- K821959CARDIO-RESPIRATORY MONITOR MODEL CR-12Cleared 510(K)
- K821755TELCOR 22Cleared 510(K)
- K821720PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 10002Cleared 510(K)
- K821223CR-92Cleared 510(K)
- K821368MODELS 78504A & 78508A PATIENT MON. SYS2Cleared 510(K)
- K821015CARE MODEL IP 4500 AUTO SCANNERR2Cleared 510(K)
- K820825CARDIAC MONITOR - RATE ALARM2Cleared 510(K)
- K820745DIASCOPE 22Cleared 510(K)
- K820671CM10 CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K820540OLLI 5652Cleared 510(K)
- K820399HS20 PORT. OPERATING ROOM MONITOR2Cleared 510(K)
- K820416#505 PORT. VITAL FUNCTIONS NEONATAL MON2Cleared 510(K)
- K820417#506 PORT. VITAL FUNCTIONS NEONATAL MON2Cleared 510(K)
- K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.2Cleared 510(K)
- K813174BRADYCARDIA ALARM2Cleared 510(K)
- K813444NIHON KOHDEN HEART MONITORS OMP 7101-022Cleared 510(K)
- K812828MODEL 2000 MONITOR2Cleared 510(K)
- K812674INFANT CARIDAC MONITOR2Cleared 510(K)
- K812147CARDIORATER CR-72Cleared 510(K)
- K812144CENTERAL MONITOR 3602Cleared 510(K)
- K812145CARDIORATER CR-32Cleared 510(K)
- K812146CARDIORATER CR-52Cleared 510(K)
- K812131PORTAPULSE2Cleared 510(K)
- K811425CARDIACMONITORS2Cleared 510(K)
- K811893NOVAMETRIX PHYSIOLOGICAL MONITOR #9102Cleared 510(K)
- K812271CENTRAL STATION MONITOR2Cleared 510(K)
- K811216RESIDENT BEDSIDE MONITOR2Cleared 510(K)
- K810755SQUINN VITATEK 500 SERIES PHYSIOL. MONI2Cleared 510(K)
- K803223ADVANCMED ELIMINATOR2Cleared 510(K)
- K802782THE CRITERION II PACING SYS. MONITOR2Cleared 510(K)
- K802182WISCONSIN HEART RATE MONITOR2Cleared 510(K)
- K802325CRITERION II PACING SYSTEM MONITORS2Cleared 510(K)
- K802204CT-1600 DIGITAL PULSE RATE MONITOR2Cleared 510(K)
- K802184HS10 PORTABLE OPERATING ROOM MONITOR2Cleared 510(K)
- K800519HEARTWATCH2Cleared 510(K)
- K801761PDS COMPUTER UNIT/VIDEO TERMINAL2Cleared 510(K)
- K800405A-V MINI CLINIC2Cleared 510(K)
- K801515ABBY II PATIENT MONITOR OR VITAL SIGNS M2Cleared 510(K)
- K800243D668 & D664 CENTRAL MONITORING SYSTEMS2Cleared 510(K)
- K800500PULSEOMETER2Cleared 510(K)
- K792226CARDIVAN BLOOD PRESSURE MONITOR2Cleared 510(K)
- K792122CHRONAEROBIC (CA-1)2Cleared 510(K)
- K792312HEART RATE MONITOR MD-12Cleared 510(K)
- K792117AIR-SHIELDS HEART RATE MONITOR2Cleared 510(K)
- K791862HEART RATE COMPUTER2Cleared 510(K)
- K790545STRESS TESTING SYSTEM, LATERAL TILTING2Cleared 510(K)
- K790544STRESS TESTING SYSTEM, MULTI-POSITION2Cleared 510(K)
- K790552AS7 & AS8 MONITORS2Cleared 510(K)
- K790644SUBMAX2Cleared 510(K)
- K790506DAISCOPE & ACCESSORIES2Cleared 510(K)
- K790454MODEL 78801A PATIENT MONITORS2Cleared 510(K)
- K790198MONITOR PLUG-IN MODEL M1106 ECG2Cleared 510(K)
- K790004MONITOR SCOPES, MODELS 9502, 95032Cleared 510(K)
- K790292MONITOR, ELECTROCARDIOSCOPE2Cleared 510(K)
- K782131PULSETAKER2Cleared 510(K)
- K782089MONITOR, HEART RATE MODEL 1032Cleared 510(K)
- K782088MONITOR, HEART RATE MODEL 1052Cleared 510(K)
- K781166MONITOR, HEART RATE2Cleared 510(K)
- K781407ERM-1012Cleared 510(K)
- K781387INSTA-PULSE HEART RATE MONITOR2Cleared 510(K)
- K781292CARDIOPNEUMOGRAPH2Cleared 510(K)
- K781255DIGITAL PANEL METER2Cleared 510(K)
- K780937MODEL 20 DIGITAL PULSE RATE MONITOR2Cleared 510(K)
- K780445LIQUID CRYSTAL DISPLAY DIGITAL WATCH2Cleared 510(K)
- K780702CSS-60 DIGITAL HEART RATE METER2Cleared 510(K)
- K780297CARDIAC MINISCOPE & MINIGRAPH2Cleared 510(K)
- K780404ECG MONITORING SYSTEM,2Cleared 510(K)
- K772332MONITOR, CARDIAC, BEDSIDE2Cleared 510(K)
- K780117CARDIOMETER2Cleared 510(K)
- K772006ACUTE CARDIAC CARE SYSTEM2Cleared 510(K)
- K772097HEARTRATE METER MODEL 650, P/N 0001192Cleared 510(K)
- K772056PHYSIOLOGICAL MONITOR MODEL 8712Cleared 510(K)
- K772053LINE CHARGER MODEL LC-1002Cleared 510(K)
- K771360ECG SCOPE MODEL 78332Cleared 510(K)
- K771199SURGIPULSE HEART RATE MONITOR2Cleared 510(K)
- K770023MONITOR, NEONATE, MODEL 78213A2Cleared 510(K)
- K770022MONITOR, NEONATAL, MODEL 78261A2Cleared 510(K)
- K770024MONITOR, NEONATAL, MODEL 78260A2Cleared 510(K)
- K770239DIGITAL HEART RATE METER2Cleared 510(K)
- K770038MONITOR, HEARTWATCH HEART RATE2Cleared 510(K)
- K761291CENTRAL STATION MONITORING SYSTEM2Cleared 510(K)
- K761076DEMODULATOR/CARDIOTACHOMETER2Cleared 510(K)
- K761211MODEL 15050A DIGITAL DISPLAY2Cleared 510(K)
- K760710PULSAR PULSE MONITOR WATCH2Cleared 510(K)
- K760803PHYSIOLOGICAL MONITOR (MODEL 870)2Cleared 510(K)
- K760593PORTABLE CARDIAC MONITOR, ABBY2Cleared 510(K)
- K760120PULSE CARDULE (MODEL 1859/1860 ECG)2Cleared 510(K)
- K760160MONITOR, PATIENT (MODEL 78333A)2Cleared 510(K)
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- DSBPlethysmograph, Impedance2Product Code
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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LIONHEART 3 MULTI-PARAMETER SIMULATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944257
- 510(k) Type
- Traditional
- Applicant
- BIO-TEK INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/1994
- Days to Decision
- 21 days
- Submission Type
- Statement