ClearanceBrief
510(k) K192703 ยท HAW Neurological Stereotaxic Instrument

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

ApplicantBrainlab AG, Munich, DE
DecisionSubstantially Equivalent, Oct 8, 2020
ReceivedSep 27, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K192703

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.