Medical Device Manufacturer · US , Hamden , CT

Advanced Medical Systems, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1988

Recent clearances: MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Advanced Medical Systems, Inc. Obstetrics & Gynecology ✕

6 devices

1-6 of 6

Cleared Aug 14, 1996

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)

Obstetrics & Gynecology · 243d

Cleared Jul 18, 1995

ULTRASOUND TRANSDUCER, MODEL US917

Obstetrics & Gynecology · 78d

Cleared Mar 01, 1995

MODEL IM77 INTRAPARTUM FETAL MONITOR

Obstetrics & Gynecology · 370d

Cleared Jul 22, 1994

ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

Obstetrics & Gynecology · 774d

Cleared Jul 11, 1991

FETAL SCALP SPIRAL ELECTRODE

Obstetrics & Gynecology · 90d

Cleared Oct 22, 1990

FETAL PULSE DETECTOR MODEL DOP-1

Obstetrics & Gynecology · 159d