Home / 510(k) Clearances / K811397

510(k) K811397

ECA by Gillco, Inc. — Product Code FOA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 2, 1981
Date Received: May 18, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Board, Cardiopulmonary
Device Class: Class I
Regulation Number: 880.6080
Review Panel: HO
Submission Type