510(k) K180487 ยท BZH Meter, Peak Flow, Spirometry
Peak.me
| Applicant | Breathe Me, Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, Oct 26, 2018 |
| Received | Feb 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180487
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.