510(k) K091919 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Sep 28, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2014 | DeVilbiss Healthcare LLC DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.