510(k) K211498 ยท OLK Pulse Oximeter For Over-The-Counter Use
Nonin OTC Pulse Oximeter Model 3250
| Applicant | Nonin Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 13, 2024 |
| Received | May 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211498
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.