510(k) K861564 ยท BWF Spirometer, Therapeutic (Incentive)
THE LUNG GYM (XLATOR AND NLATOR)
| Applicant | El-Fax Company, Inc., Ardmore PA, US |
| Decision | Substantially Equivalent, Aug 7, 1986 |
| Received | Apr 25, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861564
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.