510(k) K173868 ยท OLV Standard Polysomnograph With Electroencephalograph
Serenity Body Position Sensor, Serenity RIP Sensors
| Applicant | Neurotronics, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 2, 2018 |
| Received | Dec 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173868
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.