510(k) K902654

CDI (TM) SYSTEM 100 MONITORING SYSTEM by 3M Health Care, Ltd. — Product Code DTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1990
Date Received
June 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4410
Review Panel
CV
Submission Type