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
- K243603AeviceMD2Cleared 510(K)
- K242583AT-Patch (ATP-C130/ATP-C70)2Cleared 510(K)
- K232670HiCardi+ H1002Cleared 510(K)
- K233906S-Patch (S-Patch ExL)2Cleared 510(K)
- K231104ABPMpro2Cleared 510(K)
- K233110Carnation Ambulatory Monitor2Cleared 510(K)
- K230184Holter ECG and ABP System2Cleared 510(K)
- K231289S-Patch Ex Wearable ECG Patch2Cleared 510(K)
- K223382AeviceMD2Cleared 510(K)
- K223049CardioSTAT® ECG Test Solution2Cleared 510(K)
- K214073eWave Monitor2Cleared 510(K)
- K203638AT-Patch ECG Analysis System2Cleared 510(K)
- K210179QOCA Portable ECG Monitoring Device2Cleared 510(K)
- K220893Strados Remote Electronic Stethoscope Platform (RESP)2Cleared 510(K)
- K203168LifeLens Wireless ECG Monitor2Cleared 510(K)
- K202359Zio Monitor2Cleared 510(K)
- K201644QardioCore2Cleared 510(K)
- K210036Carnation Ambulatory Monitor (CAM)2Cleared 510(K)
- K202456M5 Recorder2Cleared 510(K)
- K201077Strados Remote Electronic Stethoscope Platform (RESP)2Cleared 510(K)
- K201040Bioflux Software II2Cleared 510(K)
- K200870Carnation Ambulatory Monitor2Cleared 510(K)
- K192556Carnation Ambulatory Monitor2Cleared 510(K)
- K191471Carnation Ambulatory Monitor2Cleared 510(K)
- K191000Carnation Ambulatory Monitor2Cleared 510(K)
- K173461ECG recorder and Arrhythmia Detector2Cleared 510(K)
- K172862Portable ECG Monitor (ECG3)2Cleared 510(K)
- K171410ePatch2Cleared 510(K)
- K171936Peerbridge Cor(TM) System2Cleared 510(K)
- K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software2Cleared 510(K)
- K163535my Patch sl2Cleared 510(K)
- K162571Bioflux Software2Cleared 510(K)
- K160704myPatch-s2Cleared 510(K)
- K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System2Cleared 510(K)
- K143513ZIO SR ECG Monitoring Service2Cleared 510(K)
- K143067Carnation Ambulatory Monitor2Cleared 510(K)
- K131190MYPATCH2Cleared 510(K)
- K130288STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE2Cleared 510(K)
- K121319ZIO PATCH2Cleared 510(K)
- K113862ZIO PATCH2Cleared 510(K)
- K113176MYSENSE HEART2Cleared 510(K)
- K110525VITALOGRAPH MODEL 7100 - VITALOJAK2Cleared 510(K)
- K111320GLOBALCARDIO2Cleared 510(K)
- K111745KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER2Cleared 510(K)
- K111180VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY2Cleared 510(K)
- K111096VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY2Cleared 510(K)
- K101022PULMOTRACK 5050 WHOLTER, MODEL 50502Cleared 510(K)
- K092785COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 23012Cleared 510(K)
- K091505COR12+2Cleared 510(K)
- K090363ZIO PATCH, MODEL Z1002Cleared 510(K)
- K083820VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C2Cleared 510(K)
- K073152PC-180 / PRINCE 180 EASY ECG MONITOR2Cleared 510(K)
- K070818MEDILOGAR4, MEDILOGAR122Cleared 510(K)
- K062007DMS 300-72Cleared 510(K)
- K050896H12+ HOLTER RECORDER2Cleared 510(K)
- K033037MODIFICATION TO GLOBALCARDIO2Cleared 510(K)
- K032103PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A2Cleared 510(K)
- K022540CARDIO ID+(RZ153+)2Cleared 510(K)
- K022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)2Cleared 510(K)
- K020825KING OF HEARTS EXPRESS + AF MONITOR2Cleared 510(K)
- K013354GLOBALCARDIO2Cleared 510(K)
- K004007DR180+OXY2Cleared 510(K)
- K001025LIFECARD CF COMPACT RECORDER2Cleared 510(K)
- K982448CARDIOLIGHT2Cleared 510(K)
- K990027OMNICORDER, MODEL 4642Cleared 510(K)
- K982384MERCATOR2Cleared 510(K)
- K973735MICROVIT MT-1002Cleared 510(K)
- K974420M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION2Cleared 510(K)
- K9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER2Cleared 510(K)
- K970298DM-400 HOLTER ECG CASSETTE RECORDER2Cleared 510(K)
- K971604ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP2Cleared 510(K)
- K970902MEDILOG FD42Cleared 510(K)
- K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)2Cleared 510(K)
- K944180MODEL 7002Cleared 510(K)
- K960925NORTHEAST MONITORING DR1802Cleared 510(K)
- K950854VITALOGRAPH 2110 SOFTWARE INTERFACE2Cleared 510(K)
- K950020HOLTER PACERCORDER(R)2Cleared 510(K)
- K951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM2Cleared 510(K)
- K943862SONICAID MODEL MR-63 AMBULATORY ECG RECORDER2Cleared 510(K)
- K942653HOLTER SSR DIGICORDER(TM)2Cleared 510(K)
- K945130BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER2Cleared 510(K)
- K942781DIGITAL HOLTER RECORDER2Cleared 510(K)
- K942862HEARTPRINT2Cleared 510(K)
- K943278TRACKER 2/TRACKER 3 HOLTER RECORDER2Cleared 510(K)
- K942438ALTAIR 6100 CASSETTE RECORDER2Cleared 510(K)
- K923664SCOLE 300 ECG RECORDER2Cleared 510(K)
- K934660R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 52112Cleared 510(K)
- K930894MULTITRAK-PLUS2Cleared 510(K)
- K932929HRV 4000EM2Cleared 510(K)
- K920572UNISCAN 24 ECG ROCORDER2Cleared 510(K)
- K921068GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 3002Cleared 510(K)
- K913600WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM2Cleared 510(K)
- K910884CARD GUARD, MODELS CG-6000 & CG-70002Cleared 510(K)
- K913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION2Cleared 510(K)
- K904177GALIX MA-6C HOLTER CASSETTE RECORDER2Cleared 510(K)
- K904176GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER2Cleared 510(K)
- K911257MR-5200 FULL DISCLOSURE SYSTEM2Cleared 510(K)
- K911097PR42Cleared 510(K)
- K912427MULTICHANNEL RECORDING SYSTEM2Cleared 510(K)
- K902766ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE2Cleared 510(K)
- K903331ROZINN 1512Cleared 510(K)
- K902486CARDIOVISTA2Cleared 510(K)
- K901251MODEL 9101 RECORDER/ANALYZER SYSTEM2Cleared 510(K)
- K895793MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION2Cleared 510(K)
- K896153MODIFIED DR-2C/PMC 1002Cleared 510(K)
- K895961MODEL MC6500 ELECTROCARDIOGRAPH2Cleared 510(K)
- K884126E-RAM2Cleared 510(K)
- K893836EPLAB (ELECTROCARDIOGRAPHIC MONITOR)2Cleared 510(K)
- K890114IMEX RHYTHM TEK2Cleared 510(K)
- K892227EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)2Cleared 510(K)
- K892067MT9000 CHART RECORDER2Cleared 510(K)
- K890647MEDILOG 9000-II AMBULATORY RECORDER2Cleared 510(K)
- K884330MODEL 463 ELECTROCARDIORECORDER RECORDER2Cleared 510(K)
- K880303POLYCORD II2Cleared 510(K)
- K884009MODEL 459 ELECTROCARDIOCORDER RECORDER2Cleared 510(K)
- K882366RHYTHMSCAN HR HOLTER RECORDER2Cleared 510(K)
- K874313MODEL 492 SSR (TM) RECORDER2Cleared 510(K)
- K874571PATIENTWATCH (TM)2Cleared 510(K)
- K873337MODEL SSR1 HOLTER MONITOR2Cleared 510(K)
- K872508MODEL MICRO FD+ AMBULATORY ECG MONITOR2Cleared 510(K)
- K871587THE TELESCAN C.A.R.E. SYSTEM2Cleared 510(K)
- K872234TRANSCOR RADIO-STETHOSCOPE MB2Cleared 510(K)
- K872229VITEL III, ECG TRANSMITTER2Cleared 510(K)
- K872246MODIFIED MODEL 9431 TELETRACE TRANSMITTER2Cleared 510(K)
- K870578NIGHTWATCH(TM) SYSTEM2Cleared 510(K)
- K871944FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)2Cleared 510(K)
- K872087UMSC HOLTER MONITORING KIT2Cleared 510(K)
- K871045DMI AMBULATORY HOLTER MONITOR2Cleared 510(K)
- K870537MODEL MICRO ST AMBULATORY ECG MONITOR2Cleared 510(K)
- K870554CASSETTE TAPE REPLAY SYSTEM2Cleared 510(K)
- K863922VERSAFLEX(TM) DELTA ST(TM) MONITOR2Cleared 510(K)
- K863863CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)2Cleared 510(K)
- K862526MINI-HOLTER, MODEL 20002Cleared 510(K)
- K862776SPECTRUM POLYCORD I RECORDER SYSTEM2Cleared 510(K)
- K854269MODEL 509A PHYSIOCORDER AMBULATORY RECORDER2Cleared 510(K)
- K860182MODEL MR-35 HOLTER RECORDER2Cleared 510(K)
- K860181MODEL MR-30 HOLTER RECORDER2Cleared 510(K)
- K853985MVM 4000 HOLTER IV RECORDER2Cleared 510(K)
- K853262CARDIO DATA PACERECORDER PR32Cleared 510(K)
- K851971SERIES 7000/HOLTER RECORDER2Cleared 510(K)
- K842349AMBULATORY PH RECORDING DEVICE2Cleared 510(K)
- K844940SPACELABS MODEL 90201 HOLTER RECORDER2Cleared 510(K)
- K844977HOLTER CURA-LITE RECORDER2Cleared 510(K)
- K841654DEL MAR AVIONICS 509 NEUROCORDER AMBUL2Cleared 510(K)
- K841472CARDIORHYTHM 20002Cleared 510(K)
- K841868MINGOGRAF 72Cleared 510(K)
- K842954CARDIONOSTICS HOLTER DURA-LITE RECORDE2Cleared 510(K)
- K833349EVENT TAPE RECORDER 82932Cleared 510(K)
- K833348RESPIRATION/8100-HEART RATE RECORDER2Cleared 510(K)
- K834257CARDIODATA PACE RECORDER2Cleared 510(K)
- K833823HOLTER PERFORMER FEATHER WEIGHT/CASS2Cleared 510(K)
- K833661ELECTROCARDIOCORDER RECORDER 4532Cleared 510(K)
- K832395HOLTA-MED RECORDER2Cleared 510(K)
- K830907AMBULATORY ECG EVENT RECORDER2Cleared 510(K)
- K830915OMAR2Cleared 510(K)
- K831262DATA IV AMBULATORY MONITOR2Cleared 510(K)
- K830489RECORDER DMI2Cleared 510(K)
- K831184CARDIO DATA PACEMAKER RECORDER2Cleared 510(K)
- K830519CHALLENGER #4502Cleared 510(K)
- K822362ALTA II ECG RECORDER2Cleared 510(K)
- K823414HOLTER KIT MODEL #5000 SERIES2Cleared 510(K)
- K822818HOLTER RECORDER & PLAYBACK/ANALYSIS SYS2Cleared 510(K)
- K822970HOLTER RECORDER2Cleared 510(K)
- K822363ALTA III ECG RECORDER2Cleared 510(K)
- K820256MEDILAC #SR4 & SR 402Cleared 510(K)
- K821516TRACKER-2 CHANNEL ECG TAPE RECORDER2Cleared 510(K)
- K821453CARDIOCASSETTE II #3632Cleared 510(K)
- K813602HOLTER PERFORMER2Cleared 510(K)
- K812920EVENT MASTER2Cleared 510(K)
- K812763ECG MEDATAPE-6012Cleared 510(K)
- K811253CASSETTE READER2Cleared 510(K)
- K810698PHARMALOG2Cleared 510(K)
- K803224ADVANCEMED HOLTER RECORDERS2Cleared 510(K)
- K803222ADVANCEMED CCU DOCUMENTOR2Cleared 510(K)
- K802564MEDICAL MAGNETIC TAPE RECORDER2Cleared 510(K)
- K801832MODEL 9200 VIS-U-SCAN2Cleared 510(K)
- K801001AMBULATORY MONITOR AM-12Cleared 510(K)
- K800214CIRCAMED I2Cleared 510(K)
- K792076MODEL 448 PACERCORDER2Cleared 510(K)
- K792079MODEL 447 ELECTROCARDIOCORDER2Cleared 510(K)
- K792078MODEL 449 ELECTROCARDIOCORDER2Cleared 510(K)
- K790757LIFEPAK 5 MONITOR, CASSETTE, #800923-012Cleared 510(K)
- K790476QUICKSCAN HOLTER II2Cleared 510(K)
- K790509CARDIOCASSETTE II, AMBULATORY ECG SYSTEM2Cleared 510(K)
- K790286RECORDER, MEDILOG II2Cleared 510(K)
- K790289PB-4 REPLAY UNIT2Cleared 510(K)
- K781843RECORDER, HOLTER ELECTROCARDIOGRAM2Cleared 510(K)
- K772027CARDIOCASSETTE II2Cleared 510(K)
- K771932RECORDER, DINMAP, MODEL 9502Cleared 510(K)
- K761074DYNAMIC RECORDER (DR-10)2Cleared 510(K)
- K760508ACCUTAPE 242Cleared 510(K)
- 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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Bioflux Software II
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201040
- 510(k) Type
- Traditional
- Applicant
- Biotricity
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/29/2020
- Days to Decision
- 119 days
- Submission Type
- Summary