510(k) K090646 ยท BZG Spirometer, Diagnostic
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
| Applicant | Chest M.I., Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 23, 2009 |
| Received | Mar 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090646
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.