510(k) K201056 ยท GEX Powered Laser Surgical Instrument
NeuroBlate System
| Applicant | Monteris Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 21, 2020 |
| Received | Apr 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201056
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.