510(k) K080299 ยท BWF Spirometer, Therapeutic (Incentive)
RESPIFIT S, MODEL RS-LR1001004
| Applicant | Eumedics Medizintechnik Und Marketing GmbH, Chicago IL, US |
| Decision | Substantially Equivalent, Jan 13, 2009 |
| Received | Feb 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080299
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.