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
- K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-11172Cleared 510(K)
- K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /0003912Cleared 510(K)
- K925346EP AMP, MODEL #9012Cleared 510(K)
- K914381HORIZON 9000/HIS OPTION AMPLIFIER2Cleared 510(K)
- K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED2Cleared 510(K)
- K910307CARDIOLAB AMPLIFIER MODULE (CAM)2Cleared 510(K)
- K894735ASC-952 PHYSIOLOGICAL AMPLIFIER2Cleared 510(K)
- K894161ASC-950 ECG AMPLIFIER2Cleared 510(K)
- K874441BARD BIOPOTENTIAL AMPLIFIER2Cleared 510(K)
- K853652BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT2Cleared 510(K)
- K813123EPC FILTER2Cleared 510(K)
- K810828NON-INVASIVE AMPLIFIER2Cleared 510(K)
- K802686HP MODEL 8880A FILTER2Cleared 510(K)
- K802282ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON2Cleared 510(K)
- K792283ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON2Cleared 510(K)
- K791964MODEL 15055A MAINFRAME2Cleared 510(K)
- K790203INTERVAL TIMER MODEL V42952Cleared 510(K)
- K780572DCG PREAMPLIFIER MODULE2Cleared 510(K)
- K780043ESIS MODULE2Cleared 510(K)
- K772132AMPLIFIER MODULE, 78211A ECG2Cleared 510(K)
- K771976ECG AMPLIFIER/R WAVE TRIGGER2Cleared 510(K)
- K771572PATIENT MONITORS MODELS 78701A/78702A2Cleared 510(K)
- K770243ELGILOY STYLET2Cleared 510(K)
- K761056DISPLAY MONITOR (MODEL 78301A)2Cleared 510(K)
- 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
- 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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ESIS MODULE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K780043
- 510(k) Type
- Traditional
- Applicant
- DATASCOPE CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/13/1978
- Days to Decision
- 35 days