510(k) K103584 ยท DQA Oximeter
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
| Applicant | Shenzhen Envisen Industry Co. Limited, Egale WI, US |
| Decision | Substantially Equivalent, Jun 10, 2011 |
| Received | Dec 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103584
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.