Medical Device Manufacturer · JP , Tokyo, 105 Japan

Omron Tateisi Electronics Co. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1985

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omron Tateisi Electronics Co. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jun 15, 1988

OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C

Cardiovascular · 63d

Cleared Jun 15, 1988

OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C

Cardiovascular · 63d

Cleared Jun 12, 1987

DIGITAL SPHYGMOMANOMETER

Cardiovascular · 66d

Cleared Apr 17, 1986

OMRON DIGITAL BP MONITOR HEM-700CP

Cardiovascular · 184d

Cleared Nov 18, 1985

OMRON DIGITAL BP MONITOR HEM-700C

Cardiovascular · 108d

Cleared Jul 31, 1985

OMRON DIGITAL BP MONITOR HEM-400C

Cardiovascular · 97d