510(k) K190058 ยท LRK Device, Anti-Snoring
PureSleep (OTC use)
| Applicant | Sleep Science Partners, Inc., Larkspur CA, US |
| Decision | Substantially Equivalent, Apr 11, 2019 |
| Received | Jan 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190058
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.