510(k) K993641 ยท BTY Calculator, Predicted Values, Pulmonary Function
METALYZER, MODEL 2; METALYZER, MODEL 3
| Applicant | Cortex Biophysik GmbH, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Dec 14, 2000 |
| Received | Oct 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993641
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.