Medical Device Manufacturer · US , Tewksbury , MA

Datex Medical Instrumentation, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1991

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datex Medical Instrumentation, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 31, 1996

AS/3 CARDIAC OUTPUT & SVO2 MODULE

Cardiovascular · 74d

Cleared Sep 05, 1991

CARDIOCAP II(TM)

Cardiovascular · 90d