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510(k) K131766

PLATINUM DRF IMAGING SYSTEM by Apelem-Dms Group — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2013
Date Received
June 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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