510(k) K142774 ยท OLV Standard Polysomnograph With Electroencephalograph
Polysmith Sleep System
| Applicant | Neurotronics, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 18, 2015 |
| Received | Sep 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142774
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.