510(k) K162014 ยท DQA Oximeter
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
| Applicant | Bluepoint Medical GmbH & Co. KG, Selmsdorf, DE |
| Decision | Substantially Equivalent, Feb 6, 2017 |
| Received | Jul 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162014
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.