FDA 510(k) Applications for Medical Device Product Code "MUD"
(Oximeter, Tissue Saturation)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K094030 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | 12/23/2010 |
| K112820 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | 01/26/2012 |
| K061960 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 | 09/05/2006 |
| K123700 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | 04/11/2013 |
| K133879 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | 04/29/2014 |
| K143675 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT Elite Absolute Tissue Oximeter | 04/10/2015 |
| K180003 | CAS Medical Systems, Inc. | FORE-SIGHT ELITE Module Tissue Oximeter | 05/10/2018 |
| K190270 | CAS Medical Systems, Inc. | FORE-SIGHT ELITE Tissue Oximeter Module | 10/21/2019 |
| K091452 | CAS MEDICAL SYSTEMS, INC. | FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) | 08/21/2009 |
| K171245 | Christie Medical Holdings, Inc. | Presygen/si-1 | 08/09/2018 |
| K182868 | Covidien llc | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | 01/08/2019 |
| K211561 | Covidien, llc | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | 12/05/2021 |
| K223651 | Edwards Lifesciences, LLC | Cerebral Adaptive Index (CAI) Algorithm | 05/26/2023 |
| K203490 | Edwards Lifesciences, LLC | FORE-SIGHT ELITE Absolute Tissue Oximeter | 02/10/2021 |
| K143219 | Hamamatsu Photonics K.K. | NIRO-200NX | 07/31/2015 |
| K162117 | Hamamatsu Photonics K.K. | NIRO-200NX DP | 10/25/2016 |
| K963903 | HUTCHINSON TECHNOLOGY, INC. | BIOSPECTROMETER-NB OXIMETER IIII | 01/27/1998 |
| K103613 | HUTCHINSON TECHNOLOGY, INC. | INPECTRA STO2 SPOT CHECK | 03/02/2011 |
| K061619 | HUTCHINSON TECHNOLOGY, INC. | INSPECTRA STO2 TISSUE OXYGENATION MONITOR | 07/12/2006 |
| K100915 | HUTCHINSON TECHNOLOGY, INC. | INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 | 04/30/2010 |
| K012759 | HUTCHINSON TECHNOLOGY, INC. | INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 | 01/17/2002 |
| K053618 | HUTCHINSON TECHNOLOGY, INC. | INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | 02/08/2006 |
| K023938 | HUTCHINSON TECHNOLOGY, INC. | MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | 12/13/2002 |
| K042020 | HUTCHINSON TECHNOLOGY, INC. | SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) | 09/15/2004 |
| K161237 | HYPERMED IMAGING, INC. | HyperView Hyperspectral Tissue Oxygenation Measurement System | 12/16/2016 |
| K061848 | HYPERMED, INC. | HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 | 11/08/2006 |
| K073656 | HYPERMED, INC. | OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM | 01/25/2008 |
| K201976 | Kent Imaging | SnapshotNIR | 11/10/2020 |
| K113507 | KENT IMAGING INC. | KENT CAMERA | 08/08/2012 |
| K163070 | KENT IMAGING INC. | Kent Camera | 05/05/2017 |
| K160526 | MASIMO CORPORATION | Masimo O3 Regional Oximeter System | 06/09/2016 |
| K162603 | MASIMO CORPORATION | Masimo O3 Regional Oximeter System | 05/26/2017 |
| K182429 | Masimo Corporation | Masimo O3 Regional Oximeter System | 06/07/2019 |
| K201432 | Masimo Corporation | Masimo O3 Regional Oximeter System | 08/29/2020 |
| K214072 | Masimo Corporation | Masimo O3 Regional Oximeter System | 05/06/2022 |
| K190334 | MIMOSA Diagnostics Inc | MIMOSA Imager | 11/01/2019 |
| K181623 | Modulated Imaging, Inc. | Clarifi Imaging System | 07/19/2018 |
| K153426 | MODULATED IMAGING, INC. | Ox-Imager CS | 12/21/2016 |
| K112826 | MOOR INSTRUMENTS LTD. | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | 10/10/2012 |
| K151305 | NONIN MEDICAL INC. | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | 08/27/2015 |
| K113215 | NONIN MEDICAL, INC. | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | 05/14/2012 |
| K102715 | NONIN MEDICAL, INC. | REGIONAL OXIMETER | 12/17/2010 |
| K090807 | NONIN MEDICAL, INC. | REGIONAL OXIMETER SYSTEM, MODEL 7600 | 06/30/2009 |
| K190560 | Nonin Medical, Inc. | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | 05/02/2019 |
| K093923 | OR-NIM MEDICAL LTD. | CEROX MODEL 3210 | 01/19/2010 |
| K100875 | OR-NIM MEDICAL LTD. | CEROX, MODEL 321OF | 01/25/2011 |
| K073407 | OR-NIM MEDICAL LTD. | PACIFICA | 02/28/2008 |
| K113656 | REFLECTANCE MEDICAL INC | CAREGUIDE OXIMETER | 07/26/2012 |
| K122645 | REFLECTANCE MEDICAL INC | MOBILE CAREGUIDE 2100 OXIMETER | 12/05/2012 |
| K130079 | REFLECTANCE MEDICAL INC | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER | 07/19/2013 |
| K133923 | REFLECTANCE MEDICAL INC | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | 04/11/2014 |
| K141496 | REFLECTANCE MEDICAL, INC. | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | 08/04/2014 |
| K080769 | SOMANETICS CORP. | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C | 05/14/2008 |
| K082327 | SOMANETICS CORP. | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | 04/03/2009 |
| K051274 | SOMANETICS CORP. | INVOS SYSTEM | 11/04/2005 |
| K091224 | SOMANETICS CORP. | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | 07/09/2009 |
| K192322 | Spectros Corporation | T-Stat 2.0 Microvascular Tissue Oximeter | 09/23/2019 |
| K081233 | SPECTROS CORPORATION | T-STAT 303 ISCHEMIA MONITORING SYSTEM | 07/28/2008 |
| K040684 | SPECTROS CORPORATION | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 | 11/05/2004 |
| K133983 | VIOPTIX INC. | INTRA. OX HANDHELD TISSUE OXIMETER | 09/12/2014 |
| K191676 | ViOptix, Inc. | Intra.Ox 2.0 Handheld Tissue Oximeter | 09/16/2019 |
| K221010 | ViOptix, Inc. | Intra.Ox 2.0 Handheld Tissue Oximeter | 05/03/2022 |
| K163472 | VIOPTIX, INC. | Intra.Ox Handheld Tissue Oximeter | 11/16/2017 |
| K141234 | VIOPTIX, INC. | ODISSEY TISSUE OXIMETER | 07/01/2014 |
| K042657 | VIOPTIX, INC. | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | 01/10/2005 |
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