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510(k) K203010

Platinum dRF Imaging System by Apelem-Dms Group — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2021
Date Received
October 1, 2020
Clearance Type
Special
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

Other clearances by Apelem-Dms Group

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  • K131766 — PLATINUM DRF IMAGING SYSTEM (December 12, 2013)

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