510(k) K223625 · GAA Needle, Aspiration And Injection, Disposable
CapnoSpot Pneumothorax Decompression Indicator
| Applicant | Pneumeric, Inc., Rochester MN, US |
| Decision | Substantially Equivalent, Mar 28, 2023 |
| Received | Dec 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223625
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.