510(k) K823712

BEL BLOOD LEVEL DETECTOR by R. Scott Bell — Product Code DTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1983
Date Received
December 10, 1982
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