510(k) K190163 ยท PDQ Neurosurgical Nerve Locator
ALARA Neuro Access Kit
| Applicant | SurGenTec, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Jul 16, 2019 |
| Received | Jan 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190163
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.