Medical Device Manufacturer · US , Tarrytown , NY

Hitachi Medical Corp. of America - FDA 510(k) Cleared Devices

32 submissions · 31 cleared · Since 1985

32

Total

31

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hitachi Medical Corp. of America Cardiovascular ✕

4 devices

1-4 of 4

Cleared Sep 04, 1990

ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND

Cardiovascular · 147d

Cleared Sep 04, 1990

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND

Cardiovascular · 147d

Cleared Mar 22, 1990

Cardiovascular · 205d

Cleared Apr 22, 1988

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE

Cardiovascular · 415d