510(k) K091319 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AUTO A-FLEX
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Aug 3, 2009 |
| Received | May 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091319
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2021 | Philips Respironics, Inc. SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators
The Philips Respironics E30 ventilator is intended to provide invasive and non-in Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.