510(k) K982014

STOCKERT COMPACT SYSTEM by Stoeckert Instrumente — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
June 8, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type