510(k) K991561 ยท BWF Spirometer, Therapeutic (Incentive)
ROADRUNNER, PEP THERAPY DEVICE
| Applicant | Dhd Healthcare Corp., Wampsville NY, US |
| Decision | Substantially Equivalent, Nov 10, 1999 |
| Received | May 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991561
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.