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
- 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
- K233521QT ECG (QTERD100)2Cleared 510(K)
- K222842V-Patch Cardiac Monitor2Cleared 510(K)
- K220795QT ECG2Cleared 510(K)
- K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor2Cleared 510(K)
- K220350KardiaMobile 6L2Cleared 510(K)
- K211668KardiaMobile Card2Cleared 510(K)
- K212160SimpleSENSE Platform2Cleared 510(K)
- K210753KardiaMobile 6L2Cleared 510(K)
- K201669SimpleSENSE2Cleared 510(K)
- K193296eCordum Cardiac Monitor (eCordum CM)2Cleared 510(K)
- K201208Halo AF Detection System2Cleared 510(K)
- K191406KardiaMobile, KardiaStation2Cleared 510(K)
- K192415Study Watch with Irregular Pulse Monitor2Cleared 510(K)
- K183319Triangle System2Cleared 510(K)
- K182396KardiaMobile, KardiaStation2Cleared 510(K)
- K181310HeartCheck Cardi Beat ECG Monitor with GEMS Mobile2Cleared 510(K)
- K183704RX-1 Rhythm Express Remote Cardiac Monitoring System2Cleared 510(K)
- K182040Coala Heart Monitor2Cleared 510(K)
- K182456Study Watch2Cleared 510(K)
- K173589Prizma2Cleared 510(K)
- K173872FibriCheck2Cleared 510(K)
- K173248CARDIOSKIN2Cleared 510(K)
- K180157QT ECG2Cleared 510(K)
- K172311BioFlux Device2Cleared 510(K)
- K171816Kardia Band System2Cleared 510(K)
- K172801ECG SENTINEL System2Cleared 510(K)
- K170506ECG Check - Universal, ECG Check - Universal Plus2Cleared 510(K)
- K170181Prizma2Cleared 510(K)
- K161431SimplECG2Cleared 510(K)
- K151013Vitaphone Tele ECG Loop Recorder2Cleared 510(K)
- K143032eMotion Faros ECG Mobile2Cleared 510(K)
- K142476Master Caution Device MCD2Cleared 510(K)
- K142743AliveCor Heart Monitor2Cleared 510(K)
- K142672AliveCor Heart Monitor2Cleared 510(K)
- K133703PHYSIOGLOVE ET SYSTEM2Cleared 510(K)
- K140933ALIVECOR HEART MONITOR2Cleared 510(K)
- K141813RHYTHMSTAR SYSTEM2Cleared 510(K)
- K130878CLOUDEKG2Cleared 510(K)
- K132206MELYS ATRIAL FIBRILLATION SCREENING MONITOR2Cleared 510(K)
- K131699EMOTION ECG MOBILE2Cleared 510(K)
- K121628EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)2Cleared 510(K)
- K122184ECG CHECK2Cleared 510(K)
- K113514SMARTHEART2Cleared 510(K)
- K100383VITAPHONE. MODEL 100 BT2Cleared 510(K)
- K093976RAISIN PERSONAL MONITOR2Cleared 510(K)
- K083174HEALTHEPOD2Cleared 510(K)
- K083630CLUE MEDICAL AND CLUE MEDICAL BASIC2Cleared 510(K)
- K083535HEARTRAK SMART ECAT2Cleared 510(K)
- K082718TEMPUSIC PATIENT MONITOR2Cleared 510(K)
- K082077BT3/6, BT122Cleared 510(K)
- K080047CARDIOSEN'C2Cleared 510(K)
- K081471ECARD AND CCARD2Cleared 510(K)
- K071130HEARTRAK AF2Cleared 510(K)
- K072385HEARTEVENT, MODEL AT2Cleared 510(K)
- K071228FIDELITY 200 CARDIAC EVENT RECORDER2Cleared 510(K)
- K063609RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER2Cleared 510(K)
- K062397SENTINEL2Cleared 510(K)
- K061780TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +2Cleared 510(K)
- K060911CG-6108 ARRHYTHMIA ECG EVENT RECORDER2Cleared 510(K)
- K060297PEPER2Cleared 510(K)
- K061977PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES2Cleared 510(K)
- K052767AFIBALERT ATRIAL FIBRILLATION DETECTOR2Cleared 510(K)
- K053378LOOP RECORDER VITAPHONE, 3100 SERIES2Cleared 510(K)
- K052556CG-7000DX-BT ECG RECORDER/TRANSMITTER2Cleared 510(K)
- K051544VITALCAREGIVING SYSTEM2Cleared 510(K)
- K051960CARDIONAVIGATOR +2Cleared 510(K)
- K050951MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-3702Cleared 510(K)
- K050940PMP4 MEDICAL WEB CENTER2Cleared 510(K)
- K050670SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS2Cleared 510(K)
- K042254PMP4 SELFCHECK ECG2Cleared 510(K)
- K040942VST32Cleared 510(K)
- K042022E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER2Cleared 510(K)
- K041308REMOTENURSE PATIENT MONITORING SYSTEM2Cleared 510(K)
- K033410TEMPUS 2000 PATIENT MONITOR, MODEL 00-00022Cleared 510(K)
- K033451HEARTRAK SMART AT/HEARTRAK SMART22Cleared 510(K)
- K032736HEART 20062Cleared 510(K)
- K031229TELZUIT CARDIAC MONITORING SYSTEM2Cleared 510(K)
- K030218PER, MODEL MEMO2Cleared 510(K)
- K020534MEDSTAR SYSTEM, MODELS 533-3002Cleared 510(K)
- K023689CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM2Cleared 510(K)
- K024365TM2005 PERSONAL MEDICAL PHONE CENTER2Cleared 510(K)
- K023418HEARTONE EVENT RECORDER AND TRANSMITTER2Cleared 510(K)
- K022073HEARTLINE RECEIVING STATION2Cleared 510(K)
- K020213NETLINK/NETSCAN2Cleared 510(K)
- K013879TM2000, MODEL 12Cleared 510(K)
- K012012ECG HOME2Cleared 510(K)
- K013175TM2000 EASYTRACE PLUS RECEIVING CENTER2Cleared 510(K)
- K012223CG-2211 SELFCHECK ECG TRANSMITTER2Cleared 510(K)
- K012407PACEART TX3 CARDIAC EVENT RECORDER2Cleared 510(K)
- K012187CG-3250 MINIRECEIVER2Cleared 510(K)
- K011345CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM2Cleared 510(K)
- K010945HEARTCARD, MODEL 52582Cleared 510(K)
- K010791REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)2Cleared 510(K)
- K010436TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-00112Cleared 510(K)
- K010794BRIDGE III RECEIVER2Cleared 510(K)
- K001634CARDIOSENTRY EVENT MONITOR, MODEL 8470-012Cleared 510(K)
- K003220PERSONAL ECG TRANSMITTER, MODEL CG-65502Cleared 510(K)
- K002310CARDIOBEEPER CB12/12, MODEL CB12/122Cleared 510(K)
- K002004ZYBIT2Cleared 510(K)
- K001091CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.012Cleared 510(K)
- K000775HEART 20052Cleared 510(K)
- K000225CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/63062Cleared 510(K)
- K994009CG-2100 ECG TRANSMITTER2Cleared 510(K)
- K993799CG-7000DX ECG RECORDER/TRANSMITTER2Cleared 510(K)
- K992696ECG MINIMONITOR, MODEL CG-50002Cleared 510(K)
- K992772CARDIOPHONICS 1000 MEMORY MONITOR2Cleared 510(K)
- K990478CARD GUARD, MODEL CG-65502Cleared 510(K)
- K992164TELEMEDICINE 20002Cleared 510(K)
- K991211EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM2Cleared 510(K)
- K991307TELEMEDICINE 20002Cleared 510(K)
- K982034E-FAX SYSTEM2Cleared 510(K)
- K983626KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II2Cleared 510(K)
- K982090PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM2Cleared 510(K)
- K982228FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-252Cleared 510(K)
- K983026PACEMAKER DATA PMD TRANSMITTER, MODEL CG-40002Cleared 510(K)
- K983582CARDIOBEEPER CB2502Cleared 510(K)
- K981119CARDIOPAL MODEL NUMBER PM202Cleared 510(K)
- K981394BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER7202Cleared 510(K)
- K980144HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER2Cleared 510(K)
- K980624CARDIOSTATION2Cleared 510(K)
- K973267TTM5000 TELEPHONIC EKG MONITOR2Cleared 510(K)
- K973863MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR2Cleared 510(K)
- K971696SENTINEL RECORDER, MODELS 471/4722Cleared 510(K)
- K972649CARDIOCALL CARDIAC EVENT RECORDER2Cleared 510(K)
- K971650RHYTHMSTAT XL2Cleared 510(K)
- K973141HEART ACCESS PLUS CARDIAC EVENT RECORDER2Cleared 510(K)
- K963725MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)2Cleared 510(K)
- K970305PRINTER INTERFACE2Cleared 510(K)
- K964836CARD GUARD, MODEL CG-71002Cleared 510(K)
- K964036CARDIOMAGIC 2000 SOFTWARE2Cleared 510(K)
- K963904P.H.D. - PERSONAL HEART DEVICE MODEL 52582Cleared 510(K)
- K962937CARDIO TEAM II2Cleared 510(K)
- K965101CARDIOBEEPER CB-12L2Cleared 510(K)
- K964888HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II2Cleared 510(K)
- K963375CARDIACMONITOR2Cleared 510(K)
- K963811CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE2Cleared 510(K)
- K954350CARD GUARD MODEL CG-65002Cleared 510(K)
- K960499HEARTRAK XL2Cleared 510(K)
- K953762HEART 400 ECG TRANSMITTER2Cleared 510(K)
- K954163RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER2Cleared 510(K)
- K961362AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE2Cleared 510(K)
- K954495PACETRAK PLUS2Cleared 510(K)
- K955060ACCELERATED TRANSMISSION PROTOCOL2Cleared 510(K)
- K952065PACEART CARDIOVOICE2Cleared 510(K)
- K951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER2Cleared 510(K)
- K945476HEARTHWATCH III(TM)2Cleared 510(K)
- K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS2Cleared 510(K)
- K944362HEARTCARD CARDIAC EVENT MONITOR2Cleared 510(K)
- K941898MEMORYTRACE ATM MODEL 42222Cleared 510(K)
- K942586CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)2Cleared 510(K)
- K943123PACETRAK2Cleared 510(K)
- K943124HEARTRAK2Cleared 510(K)
- K935909CG-1000 PERSONAL ECG TRANSMITTER2Cleared 510(K)
- K934975TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER2Cleared 510(K)
- K943931CARRYALL ENHANCEMENTS2Cleared 510(K)
- K943995IMD PSD 410 PACEMAKER TRANSMITTER2Cleared 510(K)
- K931020HEART 10012Cleared 510(K)
- K942704CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER2Cleared 510(K)
- K935586PRINCE2Cleared 510(K)
- K924486CARD GUARD, MODEL CG-90002Cleared 510(K)
- K932046LIFE-TELL T.S.S.2Cleared 510(K)
- K933021MODEL T131 MEMORY TRANSMITTER2Cleared 510(K)
- K926515CARD GUARD MODEL CG-80002Cleared 510(K)
- K930314HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE2Cleared 510(K)
- K932863E-FAX REMOTE MONITOR2Cleared 510(K)
- K933012MXT-2 12 LEAD MICRO-TRANSMITTER2Cleared 510(K)
- K931585CORFAX CARDIAC DATA TRANSMITTER2Cleared 510(K)
- K932859E-FAX RECEIVER2Cleared 510(K)
- K931296PACEART CARDIOPHONE2Cleared 510(K)
- K925639CARDIOMAGIC SOFTWARE2Cleared 510(K)
- K924187INSTANT MEMORY 20002Cleared 510(K)
- K925535CARDIOBEEPER(R) CB-IIA2Cleared 510(K)
- K922783ES1700 ECG MODULATOR2Cleared 510(K)
- K921699ES 1500 ECG DEMODULATOR2Cleared 510(K)
- K923930ELECTROCARDIOGRAPH TRANSMITTER2Cleared 510(K)
- K920984KING OF HEARTS EXPRESS (E.X.) MONITOR2Cleared 510(K)
- K923493LIFE-TEL T.R.S.2Cleared 510(K)
- K921929GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)2Cleared 510(K)
- K920765EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 12002Cleared 510(K)
- K922412ECG MODULATOR2Cleared 510(K)
- K915224CARDIOPHONICS MEMORY TRANSMITTER2Cleared 510(K)
- K915769MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR2Cleared 510(K)
- K915472ELECTROCARDIOGRAPH TRANSMITTER2Cleared 510(K)
- K912281ES1600 PARAMEDIC TELEPHONE2Cleared 510(K)
- K913533MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)2Cleared 510(K)
- K911308CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE2Cleared 510(K)
- K913400MODEL SCR-10002Cleared 510(K)
- K912084MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 42212Cleared 510(K)
- K904966DATAMED MODEL 401A TRANSRECIEVER2Cleared 510(K)
- K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELS2Cleared 510(K)
- K910451CARD GUARD, MODEL CG-2000A2Cleared 510(K)
- K910450CARD GUARD-3000 ECG TELEPHONE ADAPTER2Cleared 510(K)
- K904250MODEL 4222 AMBULATORY ECG MONITOR2Cleared 510(K)
- K903960MODEL 9444 TELETRACE II ECG MONITORING SYSTEM2Cleared 510(K)
- K902254ESCORT MODEL 400T TELEMETRY ECG MONITOR2Cleared 510(K)
- K900541LIFE-TEL CELLULAR TRANSCEIVER2Cleared 510(K)
- K901591ESCORT-LINK (MODEL E3200)2Cleared 510(K)
- K896040KING OF HEARTS CDM2Cleared 510(K)
- K895719TELEREHAB SYSTEM FOR CARDIAC REHABILITATION2Cleared 510(K)
- K896039KING OF HEARTS 1200 MONITOR2Cleared 510(K)
- K896002CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER2Cleared 510(K)
- K894856CARDIOPHONE2Cleared 510(K)
- K894540TELEMETRY RECEIVER ACCESSORY FOR THE CMS 80002Cleared 510(K)
- K894799CARDIOBEEPER MEMORY MONITOR CB 600 SERIES2Cleared 510(K)
- K894340PCI MODEL 2041-A TELEMETRY MONITOR2Cleared 510(K)
- K894277M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME2Cleared 510(K)
- K893471MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING2Cleared 510(K)
- K892370DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM2Cleared 510(K)
- K894140MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER2Cleared 510(K)
- K890558WELLSHIRE BASELINK2Cleared 510(K)
- K890508WELLSHIRE EMLINK MODEL 10002Cleared 510(K)
- K890461CARDIOBEEPER IV2Cleared 510(K)
- K884142OXINET N-7500 PULSE OXIMETRY NETWORK2Cleared 510(K)
- K883843CARDIOBEEPER II2Cleared 510(K)
- K881772SENSOCOR(TM) R-TEST 240 XL2Cleared 510(K)
- K883358TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM2Cleared 510(K)
- K880971DIGITAL MEDICINE ECG MONITOR AND RECORDER2Cleared 510(K)
- K882119TELSTETH TELEMETRIC STETHOSCOPE(TM)2Cleared 510(K)
- K882290CARD GUARD, MODEL CG-20002Cleared 510(K)
- K881986ESCORT - PORTABLE PATIENT MONITOR2Cleared 510(K)
- K880615AMBULATORY ECG DIGITAL MONITOR MODEL: TD-302Cleared 510(K)
- K880533VITEL III CM2Cleared 510(K)
- K880300CARDIOBEEPER(R) III2Cleared 510(K)
- K880626KING OF HEARTS2Cleared 510(K)
- K880283PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS2Cleared 510(K)
- K874387PCI MODEL RS100 TELEMETRY MONITOR2Cleared 510(K)
- K872869STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)2Cleared 510(K)
- K870652MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR2Cleared 510(K)
- K870527CARDIOTEAM2Cleared 510(K)
- K864293HEART TRACK2Cleared 510(K)
- K862668HEALTHPHONE(TM)2Cleared 510(K)
- K854369WEP 7604 TELEMETRY MONITOR2Cleared 510(K)
- K854013TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE2Cleared 510(K)
- K853096CMS 80002Cleared 510(K)
- K851623MODEL TRC-40 TELEMETRY RECIEVER MODULE2Cleared 510(K)
- K851624MODEL TT-185 TELEMETRY TRANSMITTER2Cleared 510(K)
- K852971#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER2Cleared 510(K)
- K842435MODEL T 101 CLINICAL TRANSMITTER2Cleared 510(K)
- K851124T-1000 ECG TRANSMITTER2Cleared 510(K)
- K851123R-1000 ECG RECEIVER2Cleared 510(K)
- K844966CARDIOBEEPER PROFILE MONITOR2Cleared 510(K)
- K842716MDE ESCORT 1000 & MDE ESCOR 20002Cleared 510(K)
- K844391NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS2Cleared 510(K)
- K842370PAGE-WRITER INTERPRETIVE CARDIOGRAPH2Cleared 510(K)
- K840587INSTANT REPLAY2Cleared 510(K)
- K840032TELEPHONE RECEIVERS R101 R1112Cleared 510(K)
- K834034MODEM ACCESSORY FOR EPI CARDIA SYS2Cleared 510(K)
- K832951MEMORY LOOP TRANSMITTER #1212Cleared 510(K)
- K831443PACELINE PATIENT TRANSMITTER MODEL 3242Cleared 510(K)
- K830903CARDIO ARRHYTHMIA TRANSMITTER C.A.T2Cleared 510(K)
- K831092PECGASYS REMOTE TRANSMISSION UNIT2Cleared 510(K)
- K830254LIFE LINE2Cleared 510(K)
- K830477CARDIOMEMO III2Cleared 510(K)
- K830028SIRECUST 4562Cleared 510(K)
- K822955MODEL 4242 TELE SYST ARRHYTHMIA MONITOR2Cleared 510(K)
- K821726MODEL 535-02 TRACE-A-PACE TRANSMITTER2Cleared 510(K)
- K820986EKG MONITORS, VARIOUS MODELS2Cleared 510(K)
- K820904EKG TELEPHONE CONVERTER2Cleared 510(K)
- K820452PHONOTRACE 20002Cleared 510(K)
- K820828SAMM2Cleared 510(K)
- K820276TELESCAN T-302Cleared 510(K)
- K812793P.E.T.2Cleared 510(K)
- K812755MODEL 535-03 TRACE A PACE2Cleared 510(K)
- K812703MODEL 9408 A TELETRACE2Cleared 510(K)
- K811464MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY2Cleared 510(K)
- K811758ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR2Cleared 510(K)
- K811512TELETRACE TELEPHONE EKG SYSTEM2Cleared 510(K)
- K810872EEG TELEPHONE RECEIVER MODEL #AFR-J2Cleared 510(K)
- K810608TRANSMITTER & RECEIVERS, TELEPHONE, ELEC2Cleared 510(K)
- K803315CRITERION II RHYTHM PROFILE MONITOR2Cleared 510(K)
- K802717HP MODEL 4710A ECG TRANSMITTER2Cleared 510(K)
- K802089CARDIOTRAK2Cleared 510(K)
- K801700UNI-RECORD I2Cleared 510(K)
- K792359MEDTRONIC MODEL 9407 TELETRACE TRANSMITT2Cleared 510(K)
- K792246MEDTRONIC MODEL 9408 TELETRACE TRANSMIT2Cleared 510(K)
- K791778MEDTRONIC MODEL 9410 TELETRACE RECEIVER2Cleared 510(K)
- K782076HT-110 MICROMINI2Cleared 510(K)
- K782059TRANSMITTER, TR-1 ECG2Cleared 510(K)
- K781986TRANSMITTER, MODEL 9406 AND 94012Cleared 510(K)
- K780158TELETRACE TELEPHONE EKG TRANSMITTER2Cleared 510(K)
- K772350PATIENT ALERT MODEL 5552Cleared 510(K)
- K772186ELECTROCARDIOGRAPH TRANSMITTER, 5362Cleared 510(K)
- K772178PACER MONITOR, PULSE WIDTH2Cleared 510(K)
- K771648COMPUTER ECG TERMINAL2Cleared 510(K)
- K770949COMPUTER ECG TELE. TRANSMISSION TERMINAL2Cleared 510(K)
- K770264PACEGUARD2Cleared 510(K)
- K760857TR-3 TRANSMITTER2Cleared 510(K)
- K7613183038 OPTION B-COMPUT. TRANS. TERMINAL2Cleared 510(K)
- K761073POCKET TRANSMITTER (PT-10)2Cleared 510(K)
- K761066ECG MONITOR (TELEPHONE ECG TRANSMITTER)2Cleared 510(K)
- K760564DEMODULATOR SERIES 14002Cleared 510(K)
- K760563ECG MODULATOR2Cleared 510(K)
- 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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Coala Heart Monitor
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182040
- 510(k) Type
- Traditional
- Applicant
- Coala Life AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/8/2019
- Days to Decision
- 193 days
- Submission Type
- Summary