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
- K241890Philips Holter Analysis System2Cleared 510(K)
- K240794Frontier X Plus2Cleared 510(K)
- K200833RX-1 Rhythm Express Remote Cardiac Monitoring System2Cleared 510(K)
- K193177CER-S2Cleared 510(K)
- K182030Faros Mobile2Cleared 510(K)
- K140847CARDIOSPY ECG HOLTER SYSTEMS2Cleared 510(K)
- K131897CV3000 HOLTER ANALYSIS SYSTEM2Cleared 510(K)
- K130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)2Cleared 510(K)
- K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)2Cleared 510(K)
- K111487NH-301 AMBULATORY ECG ANALYSIS SOFTWARE2Cleared 510(K)
- K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)2Cleared 510(K)
- K101273DYNAMIC ECG SYSTEM MODEL TLC50002Cleared 510(K)
- K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM2Cleared 510(K)
- K063339MEDICK MHM200 PERSONAL HEART MONITOR2Cleared 510(K)
- K062088PREMIER 11 HOLTER2Cleared 510(K)
- K051730MATRIX HOLTER SYSTEM, MODEL M122Cleared 510(K)
- K042782SEER MC2Cleared 510(K)
- K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM4102Cleared 510(K)
- K042108VISTA PLUS2Cleared 510(K)
- K040753R-TEST EVOLUTION 32Cleared 510(K)
- K024323CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C10002Cleared 510(K)
- K031466IQMARK DIGITAL HOLTER2Cleared 510(K)
- K012712NORAV HOLTER SYSTEM, MODEL NH-300 V1.072Cleared 510(K)
- K010396C. NET 21002Cleared 510(K)
- K0109492010 PLUS HOLTER FOR WINDOWS2Cleared 510(K)
- K004017H-SCRIBE2Cleared 510(K)
- K992706GALIX GBI -3S-LP2Cleared 510(K)
- K0039402010 PLUS HOLTER FOR WINDOWS2Cleared 510(K)
- K0037632010 PLUS HOLTER FOR WINDOWS2Cleared 510(K)
- K993788R.TEST EVOLUTION2Cleared 510(K)
- K992197MODIFICATION TO ZYMED HOLTER 20002Cleared 510(K)
- K990170HOLTER 20002Cleared 510(K)
- 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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PREMIER 11 HOLTER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K062088
- 510(k) Type
- Special
- Applicant
- DIAGNOSTIC MONITORING SOFTWARE
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/25/2006
- Days to Decision
- 32 days
- Submission Type
- Summary