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
- K220527PADnet Xpress2Cleared 510(K)
- K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBI2Cleared 510(K)
- K200567ASI Plethysmogrpah Analyzer2Cleared 510(K)
- K201046Automated ankle brachial pressure index measuring device, MESI mTABLET system2Cleared 510(K)
- K191266VitalScan ANS2Cleared 510(K)
- K172655Automated ankle brachial pressure index measuring device2Cleared 510(K)
- K173696TBL-ABI System2Cleared 510(K)
- K143152TM-ABI system2Cleared 510(K)
- K143094QuantaFlo2Cleared 510(K)
- K123921BODYTRONIC 2002Cleared 510(K)
- K121108DOPPLEX ABILITY2Cleared 510(K)
- K122281PADNET 2.02Cleared 510(K)
- K110374MAX PULSE SYSTEM2Cleared 510(K)
- K101983CRITICAL CARE ASSESSMENT2Cleared 510(K)
- K093192FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE2Cleared 510(K)
- K083735ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS2Cleared 510(K)
- K073323SA-3000P2Cleared 510(K)
- K073146PADNET+2Cleared 510(K)
- K042616BIOMEDIX PADNET LAB2Cleared 510(K)
- K023238MCPULSE2Cleared 510(K)
- K023707A16 BLOOD FLOW MEASUREMENT SYSTEM2Cleared 510(K)
- K022047PHLEBOTEST 20002Cleared 510(K)
- K990123PVR-100/VASOGRAM2Cleared 510(K)
- K983900VENOMETER2Cleared 510(K)
- K982707EC6 PLETHYSMOGRAPH2Cleared 510(K)
- K973659VASOCOR PVR 1002Cleared 510(K)
- K944395ELCAT D-PPG, PLETHYSMOGRAPH DEVICE2Cleared 510(K)
- K905114A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER2Cleared 510(K)
- K896500CWD/PPG MODULE2Cleared 510(K)
- K884624MVL/MODULAB WITH PVR MODULE2Cleared 510(K)
- K884451DOPCORD PPG2Cleared 510(K)
- K882547VARITEST2Cleared 510(K)
- K8839083D VASCULAR RECORDER2Cleared 510(K)
- K875118PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 1012Cleared 510(K)
- K872517TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM2Cleared 510(K)
- K863702PULSE CUFF RECORDER MODEL PCR1002Cleared 510(K)
- K863803VASOPULSE(TM)/MODEL 50002Cleared 510(K)
- K853331OSM-1 OXYGEN SATURATION MONITOR2Cleared 510(K)
- K853124NOVAMETRIX PULSE OXIMETER, MODEL 5002Cleared 510(K)
- K851128DIGITMATIC DM22Cleared 510(K)
- K833561LIGHT REFLECTION RHEOGRAPHY2Cleared 510(K)
- K832374PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH2Cleared 510(K)
- K832528MGI STRENGTH/FITNESS SYS-MODEL #PU-1012Cleared 510(K)
- K831955HR 100T2Cleared 510(K)
- K812609VASCULAB #VSC212Cleared 510(K)
- K801291EC-4 PLETHYSMOGRAPH2Cleared 510(K)
- K791927HEART RATE COMPUTER STRIP CHART2Cleared 510(K)
- K790999APOLLO HEART RATE INDICATOR2Cleared 510(K)
- K790450NOVATEC PRM2Cleared 510(K)
- K782132PLETHYSMOGRAPH, STRAIN GAUGE2Cleared 510(K)
- K780761ELECTRO-PLETHYSMOGRAPH2Cleared 510(K)
- K770332AMPLIFIER, PHOTOPULSE, MODEL PA132Cleared 510(K)
- K760504PLETHYSMOGRAPH (MDI SYSTEM II)2Cleared 510(K)
- 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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DOPPLEX ABILITY
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K121108
- 510(k) Type
- Traditional
- Applicant
- HUNTLEIGH HEALTHCARE
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/3/2013
- Days to Decision
- 266 days
- Submission Type
- Summary