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
- 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
- K231424HeartBeam AIMIGo(TM) System2Cleared 510(K)
- K233864ASSURE Wearable ECG2Cleared 510(K)
- K212317Eclipse MINI Model 989002Cleared 510(K)
- K222017Biotres2Cleared 510(K)
- K210758Q Patch2Cleared 510(K)
- K211709Biotres2Cleared 510(K)
- K211651Eclipse PRO2Cleared 510(K)
- K173156Integrated CardioRespiratory System2Cleared 510(K)
- K161062NR Recorder2Cleared 510(K)
- K152626H3+ Holter Recorder2Cleared 510(K)
- K142424DR300 HOLTER MONITOR2Cleared 510(K)
- K133014DMS 300-2W HOLTER ECG RECORDER2Cleared 510(K)
- K130294BRAEMAR CARDIOKEY HOLTER RECORDER2Cleared 510(K)
- K130785SEER 10002Cleared 510(K)
- K122272CARDIOMEM2Cleared 510(K)
- K112573EZSLEEP SLEEP QUALITY RECORDER2Cleared 510(K)
- K112601INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER2Cleared 510(K)
- K101969MH1 MICROHOLTER RECORDER2Cleared 510(K)
- K101024KENZ CARDY302 MAX2Cleared 510(K)
- K102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS2Cleared 510(K)
- K100310BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS2Cleared 510(K)
- K100266ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-6032Cleared 510(K)
- K083382CHROMA, MODEL: RZ153C2Cleared 510(K)
- K091054WALK400H2Cleared 510(K)
- K073545AUDICOR, HEMO AMBULATORY MONITOR2Cleared 510(K)
- K071085E3-80 PORTABLE ECG RECORDER & ANALYZER2Cleared 510(K)
- K071733DL900 SERIES HOLTER RECORDER2Cleared 510(K)
- K063042CARDIOMEM CM 3000-12BT2Cleared 510(K)
- K070014AUTO DETECT FOR TELAHEART DR200/E-A2Cleared 510(K)
- K071011MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER2Cleared 510(K)
- K062959DMS 300-2, 300-3 AND 300-42Cleared 510(K)
- K061293TELAHEART DIGITAL RECORDER2Cleared 510(K)
- K051686CARDIOMEM CM 3000-122Cleared 510(K)
- K050731SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM2Cleared 510(K)
- K043010HOLTER RECORDER H3+2Cleared 510(K)
- K042469BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER2Cleared 510(K)
- K041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER2Cleared 510(K)
- K032882RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 1002Cleared 510(K)
- K031074DIGITAL AMBULATORY ECG (HOLTER) RECORDER2Cleared 510(K)
- K032276CLICK HOLTER2Cleared 510(K)
- K032466SPIDERVIEW2Cleared 510(K)
- K030856ER800 SERIES ECG EVENT RECORDER2Cleared 510(K)
- K021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDER2Cleared 510(K)
- K021373H12+HOLTER RECORDER2Cleared 510(K)
- K011837LIFECARD CF 7 DAY2Cleared 510(K)
- K003707CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A2Cleared 510(K)
- K003520NEXAN SYSTEM, MODEL NX-3002Cleared 510(K)
- K001349CARDIOVISE ECG INTERPRETATIVE SOFTWARE2Cleared 510(K)
- K001317ARIA2Cleared 510(K)
- K001288DR180-II2Cleared 510(K)
- K000609CARDTEL, MODEL NT-1002Cleared 510(K)
- K992584PE 501 PC-ECG MONITOR2Cleared 510(K)
- K993643NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 1002Cleared 510(K)
- K993617DIGITRAKPLUS HOLTER RECORDER2Cleared 510(K)
- K993618DXP1000 HOLTER RECORDER2Cleared 510(K)
- K992425TES-202Cleared 510(K)
- K982617TRACER2Cleared 510(K)
- K982975DIGITAL ECG HOLTER RECORDER, MODEL DR5122Cleared 510(K)
- K982843CMS-20002Cleared 510(K)
- 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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H12+HOLTER RECORDER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K021373
- 510(k) Type
- Special
- Applicant
- Mortara Instrument, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/27/2002
- Days to Decision
- 57 days
- Submission Type
- Summary