510(k) K181709 ยท OLV Standard Polysomnograph With Electroencephalograph
Serenity Piezo Sensor, Serenity Thermocouple Sensor
| Applicant | Neurotronics, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Jun 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181709
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.