510(k) K202142 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Sleepware G3
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 29, 2020 |
| Received | Jul 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202142
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.