510(k) K233649 ยท GWJ Stimulator, Auditory, Evoked Response
ALGO Pro Newborn Hearing Screener (ALGO Pro)
| Applicant | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, Mar 8, 2024 |
| Received | Nov 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233649
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.