Oximeter, Tissue Saturation
FDA product code MUD · 66 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2700
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1998-01-27 – 2026-05-22
MUD
2026-05-22
MUD
2025-07-17
Masimo O3 Regional Oximeter
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MUD
2025-06-26
Lap.Ox™ Laparoscopic Tissue Oximeter
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MUD
2024-10-16
Cerebral Autoregulation Index (CAI) Algorithm
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MUD
2024-08-30
ODI-Tech
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MUD
2024-04-02
SnapshotNIR model KD205
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MUD
2024-03-01
OxiplexTS200
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MUD
2024-02-28
Intra.Ox™ 2.0 Handheld Tissue Oximeter
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MUD
2023-11-17
Edwards Algorithm for Measurement of Blood Hemoglobin
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MUD
2023-05-26
Cerebral Adaptive Index (CAI) Algorithm
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MUD
2022-05-06
Masimo O3 Regional Oximeter System
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MUD
2022-05-03
Intra.Ox 2.0 Handheld Tissue Oximeter
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MUD
2021-12-05
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
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MUD
2021-02-10
FORE-SIGHT ELITE Absolute Tissue Oximeter
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MUD
2020-11-10
SnapshotNIR
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MUD
2020-08-29
Masimo O3 Regional Oximeter System
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MUD
2019-11-01
MIMOSA Imager
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MUD
2019-10-21
FORE-SIGHT ELITE Tissue Oximeter Module
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MUD
2019-09-23
T-Stat 2.0 Microvascular Tissue Oximeter
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MUD
2019-09-16
Intra.Ox 2.0 Handheld Tissue Oximeter
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MUD
2019-06-07
Masimo O3 Regional Oximeter System
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MUD
2019-05-02
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
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MUD
2019-01-08
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
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MUD
2018-08-09
Presygen/si-1
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MUD
2018-07-19
Clarifi Imaging System
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MUD
2018-05-10
FORE-SIGHT ELITE Module Tissue Oximeter
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MUD
2017-11-16
Intra.Ox Handheld Tissue Oximeter
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MUD
2017-05-26
Masimo O3 Regional Oximeter System
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MUD
2017-05-05
Kent Camera
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MUD
2016-12-21
Ox-Imager CS
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MUD
2016-12-16
HyperView Hyperspectral Tissue Oxygenation Measurement System
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MUD
2016-10-25
NIRO-200NX DP
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MUD
2016-06-09
Masimo O3 Regional Oximeter System
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MUD
2013-07-19
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
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MUD
2013-04-11
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
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MUD
2012-12-05
MOBILE CAREGUIDE 2100 OXIMETER
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MUD
2012-10-10
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
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MUD
2012-08-08
KENT CAMERA
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MUD
2012-07-26
CAREGUIDE OXIMETER
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MUD
2012-05-14
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
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MUD
2012-01-26
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
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MUD
2011-03-02
INPECTRA STO2 SPOT CHECK
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MUD
2011-01-25
CEROX, MODEL 321OF
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MUD
2010-12-23
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
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MUD
2010-12-17
REGIONAL OXIMETER
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MUD
2010-04-30
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
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MUD
2010-01-19
CEROX MODEL 3210
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MUD
2009-08-21
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
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MUD
2009-07-09
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
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MUD
2009-06-30
REGIONAL OXIMETER SYSTEM, MODEL 7600
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MUD
2009-04-03
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
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MUD
2008-07-28
T-STAT 303 ISCHEMIA MONITORING SYSTEM
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MUD
2008-05-14
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
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MUD
2008-02-28
PACIFICA
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MUD
2008-01-25
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
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MUD
2006-11-08
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
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MUD
2006-09-05
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
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MUD
2006-07-12
INSPECTRA STO2 TISSUE OXYGENATION MONITOR
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MUD
2006-02-08
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
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MUD
2005-11-04
INVOS SYSTEM
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MUD
2005-01-10
VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
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MUD
2004-11-05
T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303
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MUD
2004-09-15
SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA)
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MUD
2002-12-13
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
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MUD
2002-01-17
INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
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MUD
1998-01-27
BIOSPECTROMETER-NB OXIMETER IIII
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