510(k) K092813 ยท BZG Spirometer, Diagnostic
ASTRASONIC SPIROMETER, MODEL 29-8000
| Applicant | Sdi Diagnostics, Inc., Easton MA, US |
| Decision | Substantially Equivalent, Jul 16, 2010 |
| Received | Sep 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092813
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.