510(k) K142325

Veenstra Instruments VDC-506 Dose Calibrator by Comecer Netherlands B.V. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2014
Date Received
August 20, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type