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
| Applicant | Medtronic, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 26, 2020 |
| Received | Apr 27, 2020 |
| Type | Special |
| FDA record | Open 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.