510(k) K130077 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR SE
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, May 21, 2013 |
| Received | Jan 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130077
| 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.