510(k) K000314 ยท BWF Spirometer, Therapeutic (Incentive)
INCENTIVE SPIROMETER
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 12, 2000 |
| Received | Feb 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000314
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.