510(k) K011088

SIII ALARM AMPLIFIER by Stockert Instrumente GmbH — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2001
Date Received
April 10, 2001
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