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
- K242662Falcon/Xpress (Falcon/Xpress)2Cleared 510(K)
- K233976VasoGuard (V10, V8, V6, V4, V2)2Cleared 510(K)
- K153762Smartdop XT62Cleared 510(K)
- K131623SMARTDOP XT2Cleared 510(K)
- K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING2Cleared 510(K)
- K111416FALCON2Cleared 510(K)
- K071730STUDIODOP VICORDER2Cleared 510(K)
- K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-12Cleared 510(K)
- K002766NICOLET VASOGUARD2Cleared 510(K)
- K990642ECHOFLOW DOPPLER BLOOD VELOCITY METER2Cleared 510(K)
- K925078SPECTRADOP2Cleared 510(K)
- K934638REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-82Cleared 510(K)
- K912409MODEL HD-207 BIDIRECTIONAL VELOCITY METER2Cleared 510(K)
- K911320EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE2Cleared 510(K)
- K910281INTRAVASCULAR IMAGING SYSTEM/MODIFIED2Cleared 510(K)
- K905157FLOSCOPE VASCULAR LAB.2Cleared 510(K)
- K905369UST-2266U-5 CW DOPPLER TRANSDUCER2Cleared 510(K)
- K896264MILLAR MIKRO-TIP DOPPLER CATHETER2Cleared 510(K)
- K890638VOLUME COMPUTATION SOFTWARE PACKAGE2Cleared 510(K)
- K890636CARDIAC COMPUTATION SOFTWARE PACKAGE2Cleared 510(K)
- K892944INTERSPEC TRANSESOPHAGEAL PROBE MODEL 45152Cleared 510(K)
- K881979RESUBMITTAL OF MI 1000C MICROIMAGER2Cleared 510(K)
- K883889TRANSESOPHAGEAL ECHO TRANSDUCER2Cleared 510(K)
- K873674SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER2Cleared 510(K)
- K881723GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER2Cleared 510(K)
- K871442BIOSOUND MMI ULTRASOUND2Cleared 510(K)
- K873989DOPPLEX ULTRASONIC DOPPLER SYSTEM2Cleared 510(K)
- K870857ABCOM 1 CARDIAC OUTPUT MONITOR2Cleared 510(K)
- K870726RT5000 ECHOCARDIOGRAPHY #H4100C/CE2Cleared 510(K)
- K871727MODIFIED RADIUS - MODEL NUMBER MM 50002Cleared 510(K)
- K871506ACUSON L538 TRANSDUCER2Cleared 510(K)
- K871416AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER2Cleared 510(K)
- K870850MOD 4822Cleared 510(K)
- K8720745 MHZ TRANSDUCER2Cleared 510(K)
- K871212MASCOT CW DOPPLER SYSTEM2Cleared 510(K)
- K870607SSD-725 ULTRASOUND SECTOR SCANNER2Cleared 510(K)
- K870150CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM2Cleared 510(K)
- K870916SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.2Cleared 510(K)
- K8649803MHZ ANNULAR ARRAY2Cleared 510(K)
- K862913CARDIOSCAN WITH DOPPLER OPTION2Cleared 510(K)
- K861596ACUSON S519 TRANSDUCER2Cleared 510(K)
- K861579ACUSON L558 TRANSDUCER2Cleared 510(K)
- K862159ACUSON S319 TRANSDUCER2Cleared 510(K)
- K861737MERIDIAN IMAGING SYSTEM2Cleared 510(K)
- K861866ACUSON L382 AND L312 TRANSDUCERS2Cleared 510(K)
- K861378ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST2Cleared 510(K)
- K860579CARDIOSCAN DOPPLER OPTION2Cleared 510(K)
- K860652ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS2Cleared 510(K)
- K854996ULTRASONIC COUPLANT GEL2Cleared 510(K)
- K853240MERIDIAN ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K853138MILLAR MIKRO-TIP DOPPLER CATHETER2Cleared 510(K)
- K850165MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD4172Cleared 510(K)
- K8516163.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA2Cleared 510(K)
- K851269DOPLETTE 102Cleared 510(K)
- K850216CARDIAC SECTOR PROBE 5.0 MHZ2Cleared 510(K)
- K850145CARDIAC SECTOR PROBE 3.5. MHZ2Cleared 510(K)
- K843058Q-DOP2Cleared 510(K)
- K842539DIAGNOSTIC ULTRASOUND 105 & 1102Cleared 510(K)
- K843953SCANHEADS ACCESS 10 10PV B102Cleared 510(K)
- K843620SCANHEADS-ACCESS 10PV, BIOSTATIC2Cleared 510(K)
- K843911ACCESS C2Cleared 510(K)
- K843165ULTRASOUND 72X & ANNULAR ARRAY SCAN-2Cleared 510(K)
- K843131ACCESS & 72X ULTRASOUND SCANHEAD UM42Cleared 510(K)
- K843129SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 82Cleared 510(K)
- K843130SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 42Cleared 510(K)
- K842460VF-PD-1202Cleared 510(K)
- K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO2Cleared 510(K)
- K840542MINI-DOPPLER ES-1002Cleared 510(K)
- K834525ANGIOSCAN FLO MAD SPECTRUM ANALYZER2Cleared 510(K)
- K832369VASCULAR RECORDER #3012Cleared 510(K)
- K833902VASOSCAN2Cleared 510(K)
- K810414USCI DOPPLER CATHETER SYSTEM2Cleared 510(K)
- 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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REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K934638
- 510(k) Type
- Traditional
- Applicant
- KOVEN TECHNOLOGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/13/1994
- Days to Decision
- 231 days
- Submission Type
- Statement