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
- K910871EDENTEC DIGITAL CHARTER MODEL 37101Cleared 510(K)
- K912929DASH IV1Cleared 510(K)
- K905856MODEL 556 MONITOR1Cleared 510(K)
- K902586GRI LASERGRAPH(TM) ECG PAPER1Cleared 510(K)
- K902230COLORADO COLOR IMAGING RECORDER1Cleared 510(K)
- K901385GABRIEL MEDICAL CLS THERMAL RECORDER1Cleared 510(K)
- K895111TYPE 9541 RECORDER, PAPER CHART1Cleared 510(K)
- K894922WR3500 AND WR3600 SERIES RECORDERS1Cleared 510(K)
- K894736MT96000 PAPER CHART RECORDER1Cleared 510(K)
- K894607PAQ10 PAPER CHART RECORDER1Cleared 510(K)
- K893561EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.1Cleared 510(K)
- K885058CARDIOCAP(TM) DR-104 REPORTER1Cleared 510(K)
- K890711DUAL GRAPH (TM) RECORDER-MONITOR1Cleared 510(K)
- K884897FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER1Cleared 510(K)
- K890142A10 ULTRASCOPE RECORDER1Cleared 510(K)
- K884911CORTRONIC SCR10001Cleared 510(K)
- K884388EDENTEC MODEL 4700 SCANNER1Cleared 510(K)
- K883315EDENTRACE MULTI-CHARTER MODEL 37001Cleared 510(K)
- K881831WS 800R THERMAL ARRAY RECORDER1Cleared 510(K)
- K881346LIFESTAT 1600 PRINTER1Cleared 510(K)
- K880781DATALOGGER CHART RECORDER1Cleared 510(K)
- K880554VSM(R) R2 PAPER CHART RECORDER1Cleared 510(K)
- K872822MODEL 78576A PAPER CHART RECORDER1Cleared 510(K)
- K870538MODEL 192 PRINTER1Cleared 510(K)
- K870119FIBRE OPTIC STRIP CHART RECORDER1Cleared 510(K)
- K870039IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM1Cleared 510(K)
- K863331SIREDOC 60 AND SIREDOC 2201Cleared 510(K)
- K862596DR-2C (MODIFICATION)1Cleared 510(K)
- K855045MODEL 535 NEO-TRAK RECORDER1Cleared 510(K)
- K854866LONG TERM RECORDER RAG 12001Cleared 510(K)
- K851625SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-20001Cleared 510(K)
- K852487FUKUDA DENSHI MODEL AU-5001-5003 THERMAL1Cleared 510(K)
- K851626SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE1Cleared 510(K)
- K851274OHMEDA MODEL 0001/0003 RECORDER1Cleared 510(K)
- K850365RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE1Cleared 510(K)
- K850487NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER1Cleared 510(K)
- K850146SIREDOC, PAPER CHART RECORDER1Cleared 510(K)
- K843836THERMAL GRAYSCALE RF-1001Cleared 510(K)
- K833000I-CHANNEL RECORDER1Cleared 510(K)
- K8329982-CHANNEL RECORDER1Cleared 510(K)
- K833656NARCOTRACE 40 - NT401Cleared 510(K)
- K832754MONITORING SYSTEM AS100-AS115 RECORD1Cleared 510(K)
- K831134PHOENIX 60/60 PROCESSOR MODULE1Cleared 510(K)
- K832012MEDICAL ELECTRONICS-PRINTER CLOCK1Cleared 510(K)
- K830321VENTURE II MONITORING SYSTEM1Cleared 510(K)
- K830315DUAL CHANNEL RECORDER #78574A1Cleared 510(K)
- K822978MINGOGRAF 4, MINGO CARD 4 & MINOCARD 31Cleared 510(K)
- K823210MODEL 525 NEO-TRAK NEONATAL RECORDER1Cleared 510(K)
- K822983MINGOCARD 7 & MINGOPHONE 71Cleared 510(K)
- K822432CENTURION CHART RECORDER1Cleared 510(K)
- K821612MODEL 16800 TREND RECORDER1Cleared 510(K)
- K821173EVENTMASTER 3 HOLTER EVENT SCANNER1Cleared 510(K)
- K820033CARDIOVUE ACCESSORY CART1Cleared 510(K)
- K812608VASCULAB #R12B1Cleared 510(K)
- K811540SPACELABS' SYSTEM AUTORECORDER1Cleared 510(K)
- K811453NOVATRACER RECORDER1Cleared 510(K)
- K811254PAPER CHART RECORDER1Cleared 510(K)
- K8101661,2,3 CHANNELL RECORDERS (AR150,AR250,-)1Cleared 510(K)
- K810169CENTRAL STATION CONTROLLER AC100/CE1001Cleared 510(K)
- K810167SINGLE CHANNELL RECORDER AR1101Cleared 510(K)
- K803225ADVANCEMED EXAMINER1Cleared 510(K)
- K801830MODEL 9300 ELECTROCARDIOVALIDATOR1Cleared 510(K)
- K801549MODEL R11 SINGLE CHANNEL CHART RECORDER1Cleared 510(K)
- K801485SERIES 602 CKG RECORDER (MODIFIED)1Cleared 510(K)
- K800851SERIES 602 CKGTM RECORDER1Cleared 510(K)
- K792105CRITIKON DUAL CHANNEL RECORDER1Cleared 510(K)
- K79209950MM WRITER MODEL CVM 95291Cleared 510(K)
- K790825LS-8 VISICORDER1Cleared 510(K)
- K781867WRITER, GEMINI-31Cleared 510(K)
- K781873RECORDER, STRIP CHART WITH PRINTER1Cleared 510(K)
- K781115PRINTER, DIGITAL1Cleared 510(K)
- K780597ECG PAPER, 3 CHANNEL1Cleared 510(K)
- K7806774600 RECORDER1Cleared 510(K)
- K780640DRY SILVER PROCESSOR MODEL 12261Cleared 510(K)
- K780245RECORDER, RE-100P HOT STYLUS STRIP CHART1Cleared 510(K)
- K780338MINYSTAG MN-11Cleared 510(K)
- K772333RECORDER, PAPER, ECG1Cleared 510(K)
- K772052PHYSIOLOGICAL RECORDER MODEL 721A1Cleared 510(K)
- K772054PHYSIOLOGICAL RECORDER MODEL 7401Cleared 510(K)
- K772048SINGLE & DUAL CHANNEL RECORDER1Cleared 510(K)
- K771372SYSTEM II1Cleared 510(K)
- K770946RECORD, MODEL 702, I.L.1Cleared 510(K)
- K770342RECORDER, CHART, MODEL 55361Cleared 510(K)
- K761077TREND ANALYZER1Cleared 510(K)
- K761055CALCULATOR PLOTTER (MODEL 9872A)1Cleared 510(K)
- K760676LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE1Cleared 510(K)
- K760539RECORDER (#78640A)1Cleared 510(K)
- 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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SYSTEM II
- Page Type
- Cleared 510(K)
- 510(k) Number
- K771372
- 510(k) Type
- Traditional
- Applicant
- IREX CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/4/1977
- Days to Decision
- 10 days