510(k) K192584 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
BEACON Caresystem Model 00002144
| Applicant | Mermaid Care A/S, Norresundby, DK |
| Decision | Substantially Equivalent, Dec 18, 2019 |
| Received | Sep 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192584
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.