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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K214065

ROSA ONE Brain application · Medtech S.A.S · decided 2022-05-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
PLANNING STATION-ROSA ONE- USA164050MEDTECHHAW03760244035127
PLANNING STATION-ROSA ONE- USA164050MEDTECHHAW03760244034922