510(k) K900815

SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL by 3M Company — Product Code DTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
February 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type