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510(k) K161880

NIVR58-T kit by Barco N.V. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2017
Date Received
July 8, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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