Rayvolve— 510(k) K220164

Substantially Equivalent

Azmed Sas

FDA 510(k) clearance K220164 for Rayvolve, Substantially Equivalent on 2022-06-02. Applicant: Azmed Sas. Device class: 2.

Clearance details

Applicant
Azmed Sas
Product code
Code QBS
Device class
Class 2
Regulation
21 CFR 892.2090
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Laval, FR
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