510(k) K223049 · DSH Recorder, Magnetic Tape, Medical
CardioSTAT® ECG Test Solution
| Applicant | Icentia, Inc., Quebec, CA |
| Decision | Substantially Equivalent, Mar 22, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223049
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.