Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- K231586Endophys Blood Pressure Monitor model BPM-302Cleared 510(K)
- K160945Endophys Blood Pressure Monitor2Cleared 510(K)
- K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box2Cleared 510(K)
- K141615ENDOPHYS BLOOD PRESSURE MONITOR2Cleared 510(K)
- K080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM2Cleared 510(K)
- K070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM2Cleared 510(K)
- K033738MONITORING SYSTEM, MODEL ARGUS PB-22002Cleared 510(K)
- K021517ABP FOR WINDOWS2Cleared 510(K)
- K013943RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 127202Cleared 510(K)
- K011865ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION2Cleared 510(K)
- K003122SMARTFLOW, MODEL SFIP 20002Cleared 510(K)
- K002742SPHYGMOCOR MX MODEL SCOR-MX2Cleared 510(K)
- K002067RADIANALYZER, MODEL 127102Cleared 510(K)
- K983250INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR2Cleared 510(K)
- K951226VITALMAX 4000/MINIPACK 3100/30002Cleared 510(K)
- K943457AS/3 PRESSURE TEMPERATURE MODULE, M-PT2Cleared 510(K)
- K921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE2Cleared 510(K)
- K925899AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-012Cleared 510(K)
- K914273A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR2Cleared 510(K)
- K912816PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE2Cleared 510(K)
- K912833CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY2Cleared 510(K)
- K903900SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.2Cleared 510(K)
- K901514XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.2Cleared 510(K)
- K896535MEDILOG OPTIMA2Cleared 510(K)
- K893232MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM2Cleared 510(K)
- K884118TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA2Cleared 510(K)
- K884938VITAL SIGNS MONITOR2Cleared 510(K)
- K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.2Cleared 510(K)
- K882093CARDIOCAP(TM) CMO-104 MONITOR2Cleared 510(K)
- K882085PROPAQ 104(TM)2Cleared 510(K)
- K880079TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/24202Cleared 510(K)
- K874338TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-26102Cleared 510(K)
- K874339TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-26202Cleared 510(K)
- K873765FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER2Cleared 510(K)
- K871720MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER2Cleared 510(K)
- K871718MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER2Cleared 510(K)
- K863042SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR2Cleared 510(K)
- K862200FORTEC MI-100, BLOOD PRESSURE METER2Cleared 510(K)
- K862455MODIFIED CARDIOCAP MONITOR2Cleared 510(K)
- K862647PHYSIOLOGICAL MONITOR, MODELS 401,402 & 4032Cleared 510(K)
- K860689SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE2Cleared 510(K)
- K850879HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR2Cleared 510(K)
- K844397POLLENEX DIGITAL SPHYGMOMANOMETER BP-40002Cleared 510(K)
- K844396POLLENEX DIGITAL SPHYGMOMANOMETER BP-20002Cleared 510(K)
- K832017LME BLOOD PRESSURE MONITOR2Cleared 510(K)
- K831481DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN2Cleared 510(K)
- K822843HTS *12Cleared 510(K)
- K822878MODEL 78553A PRESSURE PLUG-IN MODULE2Cleared 510(K)
- K811148VITA-STAT MODEL 9000-S2Cleared 510(K)
- K811147VITA-STAT MODEL 9000-A2Cleared 510(K)
- K811146VITA-STAT MODEL 8000-C2Cleared 510(K)
- K811079SYPHGMOLOG2Cleared 510(K)
- K811208MODEL 1100 SPHYGMOMANOMETER2Cleared 510(K)
- K810635ELECTRODE BLOOD PRESSURE MONITOR2Cleared 510(K)
- K810178PATIENT MONITOR CM111, 1122Cleared 510(K)
- K810171PERIPHERAL PULSE FUNCTION BLOCKS2Cleared 510(K)
- K810172PRESSURE FUNCTION BLOCKS2Cleared 510(K)
- K810179DUAL TRACE PATIENT MONITOR 116,118,1202Cleared 510(K)
- K8029256-415 FILTER, ELEMENT, 170-C2Cleared 510(K)
- K802600AMP PORTABLE PATIENT PRESSURE MONITOR2Cleared 510(K)
- K801110PRESSURE MONITOR, MODEL 1131B2Cleared 510(K)
- K800360OUTPUT DIGITAL DISPLAY MODULE, MOD. 6112Cleared 510(K)
- K792077MODEL 1981 PRESSUROMETER DATA ANALYSIS2Cleared 510(K)
- K791838HSH/H512 ADULT PHYSIOLOGICAL MONITORS2Cleared 510(K)
- K791839H59 CRITICAL CARE MONITOR2Cleared 510(K)
- K782073DINAMAP MODELS 1160 AND 11652Cleared 510(K)
- K790135MONITOR, PRESSURVEIL2Cleared 510(K)
- K781701BLOOD PRESSURE, DIGITAL MODEL #21532Cleared 510(K)
- K781064DINAMAP MODEL 8482Cleared 510(K)
- K781053DINAMAP MODEL 8462Cleared 510(K)
- K780798GOULD-STATHAM SP1405 PRESSURE MONITOR2Cleared 510(K)
- K780356OUTPUT DIGITAL DISPLAY MODULE, MODEL 4012Cleared 510(K)
- K772334MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP2Cleared 510(K)
- K771981MINIMAP MODEL 8102Cleared 510(K)
- K772234CARDIAC OUTPUT MODULE-78231C2Cleared 510(K)
- K771977CARDIAC OUTPUT COMPUTER MODEL 7012Cleared 510(K)
- K771772DINAMAP MODEL 825A2Cleared 510(K)
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- 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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SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K903900
- 510(k) Type
- Traditional
- Applicant
- PPG HELLIGE B.V.
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/8/1991
- Days to Decision
- 138 days