510(k) K053149 ยท BWF Spirometer, Therapeutic (Incentive)
SPIRO-BALL
| Applicant | Leventon, S.A., Esteve Sesrovires, Barcelona, ES |
| Decision | Substantially Equivalent, Dec 13, 2005 |
| Received | Nov 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053149
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.