510(k) K150515 ยท BZG Spirometer, Diagnostic
IQSense Flow Sensor Mouthpiece
| Applicant | Sdi Diagnostics, Inc., Easton MA, US |
| Decision | Substantially Equivalent, Jan 12, 2016 |
| Received | Mar 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150515
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.