510(k) K080921 ยท BZG Spirometer, Diagnostic
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
| Applicant | Chest M.I., Inc., Tokyo, JP |
| Decision | Substantially Equivalent, Jan 21, 2009 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080921
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.