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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).

FDA 510(k) source

510(k) number
K261469
Applicant
Barco N.V.
Decision date
Sep 30, 2026
Date received
May 4, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
DXJ
Device type
Display, Cathode-Ray Tube, Medical
Device class
Class II
Regulation
21 CFR 870.2450
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Kortrijk, BE