510(k) K131982 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AUTO A-FLEX HT
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 18, 2013 |
| Received | Jun 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto CPAP. Non-Continuous Ventilator. Open, Classified |
BZD | None listed |
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto BiPAP. Non-Continuous Ventilator. Open, Classified |
BZD | None listed |
| Aug 8, 2025 | Philips Respironics, Inc. DreamStation Auto. Non-Continuous Ventilator. Open, Classified |
BZD | None listed |
| Apr 6, 2023 | Philips Respironics, Inc. Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment o Open, Classified |
BZD | None listed |
| 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.