FDA.reportPublic FDA data

Tissue saturation oximeter sensor, single-use

Definition
A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.
GUDID devices
44
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00690103208115ForeSightEdwards Lifesciences LLCFSESNS2020-05-07
00690103208122ForeSightEdwards Lifesciences LLCFSESS2020-05-07
00690103208139ForeSightEdwards Lifesciences LLCFSESM2020-05-07
00690103208146ForeSightEdwards Lifesciences LLCFSESL2020-05-07
00690103211313ForeSightEdwards Lifesciences LLC FSESNS2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCFSESS2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCFSESM2024-08-26
00690103219616ForeSight IQEdwards Lifesciences LLCFSESLIQ2025-07-11
00851136007001Spectros T-StatSPECTROS CORPORATIONCTH-060-SUR 2.5cm2016-10-03
00851136007018Spectros T-StatSPECTROS CORPORATIONCTH-060-SUR 1cm2016-10-17
00851136007032Spectros T-StatSPECTROS CORPORATIONCHT-060-REC 5mm2016-10-17
00851136007049Spectros T-StatSPECTROS CORPORATIONCTH-060-ORA M2016-10-17
10609538710008FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10002017-03-06
10609538710022FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10022017-03-06
10609538710039FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10032017-03-06
10609538710046FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10042017-03-06
10609538710053FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10052017-03-06
10609538710060FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10062017-03-06
10609538710077FORE-SIGHT®CAS MEDICAL SYSTEMS, INC.01-07-10072017-03-06
10609538711005FORE-SIGHT ELITE®CAS MEDICAL SYSTEMS, INC.01-07-11002017-03-06
10609538711012FORE-SIGHT ELITE®CAS MEDICAL SYSTEMS, INC.01-07-11012017-03-06
10609538711029FORE-SIGHT ELITE®CAS MEDICAL SYSTEMS, INC.01-07-11022017-03-06
10609538711036FORE-SIGHT ELITE®CAS MEDICAL SYSTEMS, INC.01-07-11032017-03-06
1084399700841603 Sensor rS02 Large Adhesive SensorMASIMO CORPORATION37562017-10-12
50690103219611ForeSight IQEdwards Lifesciences LLCFSESLIQ2025-07-11
50690103211318ForeSightEdwards Lifesciences LLC FSESNS2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCFSESS2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCFSESM2024-08-26
50690103208110ForeSightEdwards Lifesciences LLCFSESNS2020-05-07
50690103208127ForeSightEdwards Lifesciences LLCFSESS2020-05-07
50690103208134ForeSightEdwards Lifesciences LLCFSESM2020-05-07
50690103208141ForeSightEdwards Lifesciences LLCFSESL2020-05-07
B426OXY2DUR10Intra.Ox Smart SensorVIOPTIX, INC.OXY2-DUR-12020-04-17
B426OXY2QCT10Intra.Ox Optical QC TargetVIOPTIX, INC.OXY2-QCT-12020-04-17
B426OXY2STH10Intra.Ox Disposable SheathVIOPTIX, INC.OXY2-STH-12020-04-17
B426OXY2SPD10T.Ox SP SensorVIOPTIX, INC.OXY-2-SPD-12016-09-26
B426OXY2SPI10T.Ox SS SensorVIOPTIX, INC.OXY2-SPI-12016-09-26
06946725524176APKAPK Technology Co.,Ltd.A1418-SA012017-03-06
06946725524183APKAPK Technology Co.,Ltd.A1418-SP012017-03-06
00851136007025Spectros T-StatSPECTROS CORPORATIONCTH-060-END 2.3M2016-10-17
10851136007008Spectros T-StatSPECTROS CORPORATIONCTH-060-SUR 2.5cm2016-10-03
10851136007015Spectros T-StatSPECTROS CORPORATIONCTH-060-SUR 1cm2016-10-17
10851136007039Spectros T-StatSPECTROS CORPORATIONCHT-060-REC 5mm2016-10-17
10851136007046Spectros T-StatSPECTROS CORPORATIONCTH-060-ORA M2016-10-17