510(k) K911358 ยท BTY Calculator, Predicted Values, Pulmonary Function
CMD/DLCO DIAGNOSTIC SPIROMETER
| Applicant | Spirometrics, Inc., Auburn ME, US |
| Decision | Substantially Equivalent, Jul 22, 1991 |
| Received | Mar 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911358
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.