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510(k) K200218

Digiscan FDX by Allengers Medical Systems Limited — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2020
Date Received
January 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Interventional fluoroscopy

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