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
- K251114FloPatch FP1202Cleared 510(K)
- K243852Elfor-L2Cleared 510(K)
- K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)2Cleared 510(K)
- K223843FloPatch FP1202Cleared 510(K)
- K222242FloPatch FP1202Cleared 510(K)
- K213974GEM FLOW COUPLER Monitor (GEM1020M-2)2Cleared 510(K)
- K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger2Cleared 510(K)
- K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger2Cleared 510(K)
- K201114Bidop 72Cleared 510(K)
- K200337FloPatch (FP120)2Cleared 510(K)
- K192966FlowMet2Cleared 510(K)
- K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes2Cleared 510(K)
- K191388FloPatch (FP110)2Cleared 510(K)
- K182494FlowMet-R2Cleared 510(K)
- K181269iCertainty2Cleared 510(K)
- K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM2Cleared 510(K)
- K152930PeriFlux60002Cleared 510(K)
- K150268CerOX2Cleared 510(K)
- K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+2Cleared 510(K)
- K140740TRANSONIC TISSUE PERFUSION MONITOR2Cleared 510(K)
- K132139DELTEX MEDICAL CARDIOQ-EDM+2Cleared 510(K)
- K131854CEROX2Cleared 510(K)
- K111730SONOTT FLOWLAB(R)2Cleared 510(K)
- K112657AUREFLO MONITORING SYSTEM2Cleared 510(K)
- K111542DELTEX MEDICAL CARDIOQ EDM2Cleared 510(K)
- K110438SENSILASE PAD-IQ2Cleared 510(K)
- K110347DOPPLER MONITOR2Cleared 510(K)
- K102595MEDISTIM VERIQC SYSTEM2Cleared 510(K)
- K102433MOORVMS-PRES PRESSURE CUFF CONTROLLER2Cleared 510(K)
- K082870VTI INTRAOPERATIVE DOPPLER SYSTEMS2Cleared 510(K)
- K062977CRITIVIEW, MODEL CRV32Cleared 510(K)
- K051145CRITIVIEW2Cleared 510(K)
- K052209VCS DOPPLER TRANSCEIVER, MODEL 09-0023-012Cleared 510(K)
- K050601SMARTDOP 45 VASCULAR DOPPLER2Cleared 510(K)
- K050088QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER2Cleared 510(K)
- K041180QUANTIX OR VESSEL STABILIZER DEVICE2Cleared 510(K)
- K040654SENSILASE PAD 30002Cleared 510(K)
- K040228MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ41222Cleared 510(K)
- K040909SONO TT ULTRASONIC FLOWCOMPUTER2Cleared 510(K)
- K031931ECHO SOUNDER EX-101EX 8 MHZ2Cleared 510(K)
- K033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT10022Cleared 510(K)
- K031153MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-050652Cleared 510(K)
- K030357QUANTIX/OR DEVICE2Cleared 510(K)
- K031706CARDIOQ, MODEL 9051-70052Cleared 510(K)
- K030505CAPIOX CARDIOTOMY RESERVOIR2Cleared 510(K)
- K031091VTI 20 MHZ GATED DOPPLER2Cleared 510(K)
- K023431QUANTIX/ND DEVICE2Cleared 510(K)
- K013376QFLOW 500 PERFUSION MONITORING SYSTEM2Cleared 510(K)
- K013803FLOWGUARD DEVICE2Cleared 510(K)
- K010452BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T2Cleared 510(K)
- K011899PF 5050 PRESSURE UNIT, MODEL PF 50502Cleared 510(K)
- K002186VASCULAR ASSIST2Cleared 510(K)
- K992529TISSUE SPECTROSCOPE2Cleared 510(K)
- K984338JOSTRA HL-20 TWIN PUMP2Cleared 510(K)
- K992387ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-41002Cleared 510(K)
- K992388ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-42002Cleared 510(K)
- K973078WRIST BLOOD PRESSURE METER MODEL SE-3302Cleared 510(K)
- K982986TUBING BLOOD FLOW METER MODEL NUMBER HD-8002Cleared 510(K)
- K973198VGF-7 VASCULAR GRAFT FLOWMETER2Cleared 510(K)
- K974285PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT2Cleared 510(K)
- K970211MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR2Cleared 510(K)
- K970139MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO2Cleared 510(K)
- K972213MS-7002Cleared 510(K)
- K972798DYNEMO 30002Cleared 510(K)
- K954397BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY2Cleared 510(K)
- K951369EDM2Cleared 510(K)
- K951486MODEL PV2000 VASCULAR MICROLABORATORY2Cleared 510(K)
- K942613SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR2Cleared 510(K)
- K932068PERITEMP PF 4005 HEATER2Cleared 510(K)
- K921377P/METER2Cleared 510(K)
- K930227MS DISPOSABLE RIGID DOPPLER PROBE2Cleared 510(K)
- K925524CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)2Cleared 510(K)
- K922034LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER2Cleared 510(K)
- K922368PERIFLUX PF4001 LASER DOPPLER FLOWMETER2Cleared 510(K)
- K922669MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW2Cleared 510(K)
- K920333SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR2Cleared 510(K)
- K915550MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR2Cleared 510(K)
- K920844PIM 1.0 LASER DOPPLER PERFUSION IMAGER2Cleared 510(K)
- K912562ABCOM 20002Cleared 510(K)
- K912446MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM22Cleared 510(K)
- K913827MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG2Cleared 510(K)
- K911763LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)2Cleared 510(K)
- K910049INTERSPEC APOGEE, MODIFICATION2Cleared 510(K)
- K905411FLOWIRE AND FLOMAP2Cleared 510(K)
- K903026ES-1000SP II SMART DOP2Cleared 510(K)
- K904317AVALON GENERAL PURPOSE SCANNER, PREVIEW GP2Cleared 510(K)
- K904792DIAGNOSTIC ULTRASOUND VERSADOPP 10002Cleared 510(K)
- K903625DOPPLER NEEDLE AND FLOW MONITOR2Cleared 510(K)
- K901015WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC2Cleared 510(K)
- K903633ADVANCE LASER FLOWMETER, ALF 212Cleared 510(K)
- K901335ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER2Cleared 510(K)
- K902088MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND2Cleared 510(K)
- K901733MODIFIED FLOCATH PULMONARY ARTERY CATHETER2Cleared 510(K)
- K896613FLAT VASCULAR PROBE2Cleared 510(K)
- K896515LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM22Cleared 510(K)
- K894631NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.2Cleared 510(K)
- K892707DVM-4200 BLOOD FLOWMETER2Cleared 510(K)
- K890828PERIFLUX PF32Cleared 510(K)
- K882138IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER2Cleared 510(K)
- K875179MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A2Cleared 510(K)
- K882593MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM2Cleared 510(K)
- K872048TRANSONIC FLOWMETER2Cleared 510(K)
- K874885LAWRENCE L3000 CARDIAC OUTPUT MONITOR2Cleared 510(K)
- K871490COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION2Cleared 510(K)
- K872068HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD2Cleared 510(K)
- K864259MODIFIED LASERFLO BLOOD PERFUSION MONITOR2Cleared 510(K)
- K853952METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME2Cleared 510(K)
- K863210VELCOM-1002Cleared 510(K)
- K862720VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES2Cleared 510(K)
- K861023DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER2Cleared 510(K)
- K862841HIGH VELOCITY CW DOPPLER SYSTEM2Cleared 510(K)
- K860766MILLAR PULSED DOPPLER VELOCIMETER2Cleared 510(K)
- K860651MICRON, MICROVASCULAR DOPPLER2Cleared 510(K)
- K854500HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -2Cleared 510(K)
- K850137TECA TC2-64 TRANSCRANIAL DOPPLER2Cleared 510(K)
- K851057LASERFLO BLOOD PERFUSION MONITOR 4032Cleared 510(K)
- K840522RECOMED BLOOD-FLOW METER H236-052-022Cleared 510(K)
- K840169PHONOANGIOGRAPHIC SPECTRAL ANALYZER2Cleared 510(K)
- K844631PERIFLUX PF-22Cleared 510(K)
- K821373XOMED PATENCY MONITOR2Cleared 510(K)
- K820742NIHON KOHDEN BLOOD FLOWMETERS #MFV-11002Cleared 510(K)
- K820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SY2Cleared 510(K)
- K812005CAPILLARY PERFUSION MONITOR #LD50002Cleared 510(K)
- K811616BACH-SIMPSON MODEL TS2662Cleared 510(K)
- K811615BACH-SIMPSON MODEL BVM302Cleared 510(K)
- K811376ULTRASONIC QFM SYSTEM 10002Cleared 510(K)
- K811246DOPPLER ULTRASOUND BLOOD FLOWMETER2Cleared 510(K)
- K810561DOPSCAN MODEL 10502Cleared 510(K)
- K801802ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE2Cleared 510(K)
- K800151EMIT TOBRAMYCIN CONTROL2Cleared 510(K)
- K791418VASCULIZER2Cleared 510(K)
- K780302BLOOD FLOWMETER SYSTEM2Cleared 510(K)
- K770115ARTERIAL DIAGNOSTIC UNIT (ADU)2Cleared 510(K)
- K761288P-1 ULTRASONIC ARTERIOGRAPH2Cleared 510(K)
- K760751CONTINUOUS WAVE DOPPLER2Cleared 510(K)
- 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
- 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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ECHO SOUNDER EX-101EX 8 MHZ
- Page Type
- Cleared 510(K)
- 510(k) Number
- K031931
- 510(k) Type
- Traditional
- Applicant
- KOVEN TECHNOLOGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/13/2004
- Days to Decision
- 235 days
- Submission Type
- Summary