510(k) K133064 ยท DQA Oximeter
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
| Applicant | Envitec-Wismar GmbH, Egale WI, US |
| Decision | Substantially Equivalent, May 2, 2014 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133064
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.