Medical Device Manufacturer · US , Mchenry , IL

Roche Medical Electronics, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1976

16

Total

16

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Sep 04, 1979

FETASONDE FETAL ACTIVITY MONITOR

Obstetrics & Gynecology · 91d

Cleared Sep 04, 1979

FETASONDE UTERINE WORK MONITOR

Obstetrics & Gynecology · 91d

Cleared Sep 04, 1979

FETASONDE LABOR STATUS DISPLAY

Obstetrics & Gynecology · 91d

Cleared Sep 04, 1979

FETASONDE UTERINE ACTIVITY MONITOR

Obstetrics & Gynecology · 91d

Cleared Sep 04, 1979

FETASONDE FETAL HEART RATE VARIABILITY

Obstetrics & Gynecology · 91d

Cleared Jun 01, 1979

FETASONDE MODEL 2108

Obstetrics & Gynecology · 45d

Cleared Oct 19, 1977

ROCHE AXISCAN 5

Obstetrics & Gynecology · 22d

Cleared Nov 16, 1976

MODEL 2106 FETA SONDE FETAL MONITOR

Obstetrics & Gynecology · 19d