510(k) K190561 ยท BZL Computer, Oxygen-Uptake
NICU V'02
| Applicant | Cosmed Nordic Aps, Odense, DK |
| Decision | Substantially Equivalent, Sep 4, 2020 |
| Received | Mar 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190561
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.