510(k) K150572 ยท LRK Device, Anti-Snoring
Respire Pink Series-Herbst-EF
| Applicant | Respire Medical Holding, Brooklyn NY, US |
| Decision | Substantially Equivalent, Aug 27, 2015 |
| Received | Mar 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2018 | Respire Medical Respire Pink Series EF+ Oral Sleep Apnea Device. Terminated |
LRK | None listed |
| May 29, 2018 | Respire Medical Respire Pink+ Hard/Soft Oral Sleep Apnea Device Terminated |
LRK | None listed |
| May 29, 2018 | Respire Medical Respire Pink+ Hard Oral Sleep Apnea Device Terminated |
LRK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.