Medical Device Manufacturer · US , Walker , MI

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

13 submissions · 12 cleared · Since 1981

13

Total

12

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared May 09, 1991

GLOVE-N-GEL AMNIOTOMY KIT

Obstetrics & Gynecology · 92d

Cleared Jan 31, 1991

INTRAUTERINE CATHETER SET

Obstetrics & Gynecology · 34d

Cleared Jun 14, 1988

Obstetrics & Gynecology · 71d

Cleared Jul 13, 1987

FETALFLEX FETAL ELECTRODE

Obstetrics & Gynecology · 117d

Cleared Jun 19, 1984

OBSTETRICAL DOPPLER

Obstetrics & Gynecology · 49d

Cleared Aug 12, 1983

EPCOM EMS-310 INTRAPARTUM MONITOR

Obstetrics & Gynecology · 129d

Cleared Aug 12, 1983

EPCOM EMS-330 FREEDOM I TELEDOP OBSTET

Obstetrics & Gynecology · 129d

Cleared Aug 12, 1983

EPCOM EMS-320 REMOTE MONITORSCOPE

Obstetrics & Gynecology · 129d

Cleared Jun 30, 1983

EPCOM VCU-1 VACUUM SYSTEM & CURETTE

Obstetrics & Gynecology · 86d

Cleared Dec 10, 1981

EPCOM EMS-180 ANTEPARTUM FETAL MONITOR

Obstetrics & Gynecology · 44d