510(k) K200986 · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
OPTI® B-Lac Cassette
| Applicant | Opti Medical Systems, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Aug 2, 2021 |
| Received | Apr 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200986
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.