510(k) K042374

STOCKERT SCP RHYTHM by Stockert Instrumente GmbH — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2004
Date Received
September 1, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type