510(k) K961364

AUTOMATIC TUBING CLAMP SYSTEM (ATC) by Rocky Mountain Research, Inc. — Product Code KRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1996
Date Received
April 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type