Medical Device Manufacturer · US , Troy , MI

Somanetics Corp. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1990

Recent clearances: VITAL SYNC MODEL 5000 SERIES, OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S, INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Somanetics Corp. Anesthesiology ✕

4 devices

1-4 of 4

Cleared Sep 15, 2000

ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100

Anesthesiology · 88d

Cleared Oct 10, 1997

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

Anesthesiology · 161d

Cleared Jun 05, 1996

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

Anesthesiology · 113d

Cleared May 18, 1990

CAV SAT OXIMETER MODEL 100

Anesthesiology · 410d