510(k) K012368 ยท BWF Spirometer, Therapeutic (Incentive)
AEROPEP
| Applicant | Trudell Medical Intl., London, CA |
| Decision | Substantially Equivalent, Feb 12, 2002 |
| Received | Jul 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012368
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.