Medical Device Manufacturer · US , Scotts Valley , CA

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

3 submissions · 3 cleared · Since 1998

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amira Medical, Inc. Chemistry ✕

3 devices

1-3 of 3

Cleared May 07, 2001

ATLAST DATA MANAGEMENT SOFTWARE (DMS)

Chemistry · 68d

Cleared May 10, 1999

ATLAST GLUCOSE CONTROL SOLUTION

Chemistry · 40d

Cleared Dec 10, 1998

AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM

Chemistry · 181d