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
- K233076Laser Speckle Imaging System (RFLSI CZW)2Cleared 510(K)
- K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.02Cleared 510(K)
- K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager2Cleared 510(K)
- K142932Deltex Medical KDP72 Doppler Probe2Cleared 510(K)
- K132730BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE2Cleared 510(K)
- K133903BIO-PROBE TRANSDUCER (ADULT)2Cleared 510(K)
- K132163MOORLDLS-BI LASER DOPPLER BURNS IMAGER2Cleared 510(K)
- K124049DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM2Cleared 510(K)
- K123216AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN2Cleared 510(K)
- K122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER2Cleared 510(K)
- K121429AIMAGO EASYLDI MICROCIRCULATION CAMERA2Cleared 510(K)
- K120884PERICAM PSI2Cleared 510(K)
- K073593I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-70162Cleared 510(K)
- K060976MOORLD12-B1 LASER DOPPLER BURNS IMAGER2Cleared 510(K)
- K063586MOORFLPI FULL-FIELD LASER PERFUSION IMAGER2Cleared 510(K)
- K063561MOORLDLS LASER DOPPLER LINE SCANNER2Cleared 510(K)
- K052989DP240 240 HOUR DOPPLER PROBE2Cleared 510(K)
- K032841MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR2Cleared 510(K)
- K013939JOSTRA FLOWPROBE FP-32E2Cleared 510(K)
- K012747TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)2Cleared 510(K)
- K980383MOOORLDI LASER DOPPLER IMAGER2Cleared 510(K)
- K963703ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)2Cleared 510(K)
- K962700VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT2Cleared 510(K)
- K961368TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT2Cleared 510(K)
- K951832LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-4332Cleared 510(K)
- K942377TRANSTAR PRESSURE TRANSDUCER2Cleared 510(K)
- K924208BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)2Cleared 510(K)
- K902977K3 COMPUTER SYSTEMS2Cleared 510(K)
- K912404TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY2Cleared 510(K)
- K910441FLOSCOPE MICRODOP2Cleared 510(K)
- K905728SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K896435HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM2Cleared 510(K)
- K881303TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER2Cleared 510(K)
- K874138ACCUCOM 22Cleared 510(K)
- K873214APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H43002Cleared 510(K)
- K874861ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.2Cleared 510(K)
- K875266SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM2Cleared 510(K)
- K873673BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL2Cleared 510(K)
- K872441HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR2Cleared 510(K)
- K871912PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM2Cleared 510(K)
- K873041A-V RECORDER2Cleared 510(K)
- K863372SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES2Cleared 510(K)
- K860121INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER2Cleared 510(K)
- K860435MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER2Cleared 510(K)
- K830858BIO-PROBE SYSTEM-BLOOD FLOW PROBE2Cleared 510(K)
- K792015P-2 ULTRASONIC ARTERIOGRAPH2Cleared 510(K)
- K781413MASK, PXYGEN2Cleared 510(K)
- 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
- 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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ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K963703
- 510(k) Type
- Traditional
- Applicant
- INTERNATIONAL BIOPHYSICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/8/1998
- Days to Decision
- 569 days
- Submission Type
- Summary