510(k) K103360

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL by Siemens Corp. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2010
Date Received
November 16, 2010
Clearance Type
Traditional
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