MDPC-8127— 510(k) K203364

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K203364 for MDPC-8127, Substantially Equivalent on 2021-04-15. Applicant: Barco N.V.. Device class: 2.

Clearance details

Applicant
Barco N.V.
Product code
Code PSY
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kortrijk, BE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.