510(k) K980550 ยท BZH Meter, Peak Flow, Spirometry
WHISTLE WATCH
| Applicant | Harwill Medical (Pty) , Ltd., Crofton MD, US |
| Decision | Substantially Equivalent, Aug 27, 1998 |
| Received | Feb 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980550
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.