ClearanceBrief
510(k) K201118 ยท GWM Device, Monitoring, Intracranial Pressure

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

ApplicantMedtronic, Inc., Irvine CA, US
DecisionSubstantially Equivalent, May 26, 2020
ReceivedApr 27, 2020
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K201118

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.