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 |