510(k) K172986 ยท OLV Standard Polysomnograph With Electroencephalograph
Zmachine Synergy
| Applicant | Consolidated Research of Richmond, Inc. Dba General Sleep CO, Cleveland OH, US |
| Decision | Substantially Equivalent, Dec 19, 2017 |
| Received | Sep 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172986
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.