510(k) K000648 ยท BTY Calculator, Predicted Values, Pulmonary Function
SPIRO PRO
| Applicant | Erich Jaeger GmbH, Yorba Linda CA, US |
| Decision | Substantially Equivalent, Mar 29, 2000 |
| Received | Feb 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000648
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.