510(k) K141728

ACE CALIBRATOR by SENTINEL CH. SpA — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2014
Date Received
June 26, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type