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510(k) K203428

Ziehm Vision RFD by Ziehm Imaging GmbH — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2021
Date Received
November 20, 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

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