510(k) K101031 ยท DQA Oximeter
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | Apr 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101031
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.