510(k) K974848 ยท BWF Spirometer, Therapeutic (Incentive)
MINI-CISER
| Applicant | Hougen Mfg., Inc., Swartz Creek MI, US |
| Decision | Substantially Equivalent, Aug 6, 1998 |
| Received | Dec 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974848
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.