510(k) K111053 ยท BTY Calculator, Predicted Values, Pulmonary Function
SENTRYSUITE PRODUCT LINE
| Applicant | Carefusion Germany 234 GmbH, Hoechberg, DE |
| Decision | Substantially Equivalent, Aug 12, 2011 |
| Received | Apr 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111053
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.