510(k) K001278 ยท BZG Spirometer, Diagnostic
SENSAIRE DIAGNOSTIC SPIROMETER
| Applicant | Qrs Diagnostic, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 29, 2000 |
| Received | Apr 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001278
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.