510(k) K112220 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
| Applicant | Devilbiss Healthcare, LLC, Somerset PA, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Aug 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112220
| 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.