510(k) K031194 ยท BTY Calculator, Predicted Values, Pulmonary Function
SPIROSOFT
| Applicant | Viasys Healthcare GmbH, Yorba Linda CA, US |
| Decision | Substantially Equivalent, Jul 30, 2003 |
| Received | Apr 16, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031194
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.