510(k) K161650 ยท OLV Standard Polysomnograph With Electroencephalograph
Polysmith Sleep System, Model NTI7593
| Applicant | Neurotronics, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jan 19, 2017 |
| Received | Jun 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161650
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.