ClearanceBrief
510(k) K250285 ยท GWM Device, Monitoring, Intracranial Pressure

NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); N

ApplicantRaumedic AG, Helmbrechts, DE
DecisionSubstantially Equivalent, Aug 29, 2025
ReceivedJan 31, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250285

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.