510(k) K811028

PACE AID by Cardiac Resucitator Corp.

K811028 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "PACE AID". The FDA issued a decision of SESP on April 16, 1981. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
April 16, 1981
Date Received
April 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No