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
- 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
- K243324Masimo O3 Regional Oximeter2Cleared 510(K)
- K250519Lap.Ox™ Laparoscopic Tissue Oximeter2Cleared 510(K)
- K240596Cerebral Autoregulation Index (CAI) Algorithm2Cleared 510(K)
- K241393ODI-Tech2Cleared 510(K)
- K240601SnapshotNIR model KD2052Cleared 510(K)
- K232385OxiplexTS2002Cleared 510(K)
- K233488Intra.Ox™ 2.0 Handheld Tissue Oximeter2Cleared 510(K)
- K230612Edwards Algorithm for Measurement of Blood Hemoglobin2Cleared 510(K)
- K223651Cerebral Adaptive Index (CAI) Algorithm2Cleared 510(K)
- K214072Masimo O3 Regional Oximeter System2Cleared 510(K)
- K221010Intra.Ox 2.0 Handheld Tissue Oximeter2Cleared 510(K)
- K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)2Cleared 510(K)
- K203490FORE-SIGHT ELITE Absolute Tissue Oximeter2Cleared 510(K)
- K201976SnapshotNIR2Cleared 510(K)
- K201432Masimo O3 Regional Oximeter System2Cleared 510(K)
- K190334MIMOSA Imager2Cleared 510(K)
- K190270FORE-SIGHT ELITE Tissue Oximeter Module2Cleared 510(K)
- K192322T-Stat 2.0 Microvascular Tissue Oximeter2Cleared 510(K)
- K191676Intra.Ox 2.0 Handheld Tissue Oximeter2Cleared 510(K)
- K182429Masimo O3 Regional Oximeter System2Cleared 510(K)
- K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface2Cleared 510(K)
- K182868INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor2Cleared 510(K)
- K171245Presygen/si-12Cleared 510(K)
- K181623Clarifi Imaging System2Cleared 510(K)
- K180003FORE-SIGHT ELITE Module Tissue Oximeter2Cleared 510(K)
- K163472Intra.Ox Handheld Tissue Oximeter2Cleared 510(K)
- K162603Masimo O3 Regional Oximeter System2Cleared 510(K)
- K163070Kent Camera2Cleared 510(K)
- K153426Ox-Imager CS2Cleared 510(K)
- K161237HyperView Hyperspectral Tissue Oxygenation Measurement System2Cleared 510(K)
- K162117NIRO-200NX DP2Cleared 510(K)
- K160526Masimo O3 Regional Oximeter System2Cleared 510(K)
- K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)2Cleared 510(K)
- K143219NIRO-200NX2Cleared 510(K)
- K143675FORE-SIGHT Elite Absolute Tissue Oximeter2Cleared 510(K)
- K133983INTRA. OX HANDHELD TISSUE OXIMETER2Cleared 510(K)
- K141496MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER2Cleared 510(K)
- K141234ODISSEY TISSUE OXIMETER2Cleared 510(K)
- K133879FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER2Cleared 510(K)
- K133923MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET2Cleared 510(K)
- K130079MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER2Cleared 510(K)
- K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER2Cleared 510(K)
- K122645MOBILE CAREGUIDE 2100 OXIMETER2Cleared 510(K)
- K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR2Cleared 510(K)
- K113507KENT CAMERA2Cleared 510(K)
- K113656CAREGUIDE OXIMETER2Cleared 510(K)
- K113215MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY2Cleared 510(K)
- K112820FORE-SIGHT ABSOLUTE TISSUE OXIMETER2Cleared 510(K)
- K103613INPECTRA STO2 SPOT CHECK2Cleared 510(K)
- K100875CEROX, MODEL 321OF2Cleared 510(K)
- K094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC20302Cleared 510(K)
- K102715REGIONAL OXIMETER2Cleared 510(K)
- K100915INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 6502Cleared 510(K)
- K093923CEROX MODEL 32102Cleared 510(K)
- K091452FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)2Cleared 510(K)
- K091224OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S2Cleared 510(K)
- K090807REGIONAL OXIMETER SYSTEM, MODEL 76002Cleared 510(K)
- K082327INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C2Cleared 510(K)
- K081233T-STAT 303 ISCHEMIA MONITORING SYSTEM2Cleared 510(K)
- K080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C2Cleared 510(K)
- K073407PACIFICA2Cleared 510(K)
- K073656OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM2Cleared 510(K)
- K061848HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU12Cleared 510(K)
- K061960FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 20402Cleared 510(K)
- K061619INSPECTRA STO2 TISSUE OXYGENATION MONITOR2Cleared 510(K)
- K053618INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 3252Cleared 510(K)
- K051274INVOS SYSTEM2Cleared 510(K)
- K042657VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-22Cleared 510(K)
- K040684T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 3032Cleared 510(K)
- K042020SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)2Cleared 510(K)
- K023938MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 3252Cleared 510(K)
- K012759INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 3252Cleared 510(K)
- K963903BIOSPECTROMETER-NB OXIMETER IIII2Cleared 510(K)
- 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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Intra.Ox 2.0 Handheld Tissue Oximeter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K221010
- 510(k) Type
- Special
- Applicant
- ViOptix, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/3/2022
- Days to Decision
- 28 days
- Submission Type
- Summary