510(k) K071689 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS INTELLIPAP MODEL DV 5 SERIES
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Sep 7, 2007 |
| Received | Jun 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071689
| 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 |
| Aug 10, 2011 | Sunrise Medical HHG Inc. dba DeVilbiss Healthcare DeVilbiss Model DV5x Series CPAP with Heated Humidifier
Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the p Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.