ClearanceBrief
510(k) K214065 ยท HAW Neurological Stereotaxic Instrument

ROSA ONE Brain application

ApplicantMedtech S.A.S, Mauguio, FR
DecisionSubstantially Equivalent, May 4, 2022
ReceivedDec 27, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K214065

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.