510(k) K161408

Compass Cast and MAP by Centurion Medical Products Corporation — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2016
Date Received
May 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type