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
- K251367OptoMonitor 32Cleared 510(K)
- K241418OptoMonitor 32Cleared 510(K)
- K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_2Cleared 510(K)
- K222216TruWave Disposable Pressure Transducer2Cleared 510(K)
- K202943OptoMonitor 32Cleared 510(K)
- K193620OptoMonitor 32Cleared 510(K)
- K193279Comet II Pressure Guidewire2Cleared 510(K)
- K192340OptoMonitor2Cleared 510(K)
- K190852Zurich Pressure Guidewire System Model 1002Cleared 510(K)
- K183413TruWave Disposable Pressure Transducer2Cleared 510(K)
- K180558PressureWire X2Cleared 510(K)
- K171996TruWave Disposable Pressure Transducer2Cleared 510(K)
- K163376Mikro-Cath Pressure Catheter2Cleared 510(K)
- K161263OptoMonitor II2Cleared 510(K)
- K161171PressureWire X Guidewire2Cleared 510(K)
- K151610Comet Pressure Guidewire2Cleared 510(K)
- K142749TruWave Disposable Pressure Transducer2Cleared 510(K)
- K140466PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 3002Cleared 510(K)
- K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K132474CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER2Cleared 510(K)
- K131452PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 3002Cleared 510(K)
- K113584PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER2Cleared 510(K)
- K112323CARDIA-CATH2Cleared 510(K)
- K093111MIKRO-CATH, MODEL 825-01012Cleared 510(K)
- K080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER2Cleared 510(K)
- K070487SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX2Cleared 510(K)
- K062769PRESSUREWIRE CERTUS, MODELS 12006 AND 123062Cleared 510(K)
- K053016WIRELESS PHYSIOLOGIC MONITORING SYSTEM2Cleared 510(K)
- K031662PRESSURE WIRE SENSOR, MODELS 12004/123042Cleared 510(K)
- K022187PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/123042Cleared 510(K)
- K935166FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER2Cleared 510(K)
- K941283INNERSENSE DISPOSABLE MICROTRANSDUCER2Cleared 510(K)
- K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-6002Cleared 510(K)
- K924737INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER2Cleared 510(K)
- K920580TRANSDUCER, PRESSURE, CATHETER TIP2Cleared 510(K)
- K913042MODIFICATIONS TO SERIES OF CARDIAC CATHETERS2Cleared 510(K)
- K915775MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN2Cleared 510(K)
- K910429SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER2Cleared 510(K)
- K895721MILLAR MIKRO-TIP PULSE TRANSDUCER2Cleared 510(K)
- K894033DISPOSABLE CATHETER PRESSURE TRANSDUCER2Cleared 510(K)
- K894747PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.2Cleared 510(K)
- K894286PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER2Cleared 510(K)
- K890492PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.2Cleared 510(K)
- K883202ULTRASONIC IMAGING CATHETER2Cleared 510(K)
- K883436PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER2Cleared 510(K)
- K880830SENTORR ARTERIAL PRESSURE SENSOR2Cleared 510(K)
- K882031VITALERT 2000 VITAL SIGNS MONITOR2Cleared 510(K)
- K874165DISPOSABLE CATHETER PRESSURE TRANSDUCER2Cleared 510(K)
- K872291ESCORT PORTABLE PATIENT MONITOR2Cleared 510(K)
- K863969CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D2Cleared 510(K)
- K864000FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-002Cleared 510(K)
- K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH2Cleared 510(K)
- K843969MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER2Cleared 510(K)
- K842213VSM R12Cleared 510(K)
- K842150TRANSDUCER-MONITOR INTERFACING2Cleared 510(K)
- K842005MODEL 110-5 & 140-82Cleared 510(K)
- K834040MINATURE PRESSURE TRANSDUCER2Cleared 510(K)
- K832384BP TRANSDUCER HOLDERS TH-2,3 & 42Cleared 510(K)
- K832604PHYSIOLOGICAL PRESSURE MEASUREMENT CATH2Cleared 510(K)
- K832579PHYSIOLOGICAL PRESS. MEASUREMENT CATH2Cleared 510(K)
- K830638PHYSIOLOGICAL PRESSURE MEASUREMENT SYS2Cleared 510(K)
- K801756MMI/GAELTEC CATHETER TIP TRANSDUC2Cleared 510(K)
- K792177MILLAR MIKRO-TIP CATHETER TRANSDUCER2Cleared 510(K)
- K790036DIGITAL BPM2Cleared 510(K)
- 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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OptoMonitor II
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K161263
- 510(k) Type
- Traditional
- Applicant
- Opsens, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/13/2016
- Days to Decision
- 131 days
- Submission Type
- Summary