Nio Color 2MP (MDNC-2123)— 510(k) K171812

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K171812 for Nio Color 2MP (MDNC-2123), Substantially Equivalent on 2017-07-19. Applicant: Barco N.V.. Device class: 2.

Clearance details

Applicant
Barco N.V.
Product code
Code PGY
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Kortrijk, BE
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