RADIANCE V2— 510(k) K133655

Name: FDA 510(k) clearance K133655
Creator: U.S. Food and Drug Administration
Published: 2014-01-31

Substantially Equivalent

Gmv Soluciones Globales Internet S.A.U.

FDA 510(k) clearance K133655 for RADIANCE V2, Substantially Equivalent on 2014-01-31. Applicant: Gmv Soluciones Globales Internet S.A.U.. Device class: 2.

Clearance details

Applicant: Gmv Soluciones Globales Internet S.A.U.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2013-11-27
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Noord Holland, NL

Download summary PDF View on FDA.gov ↗

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