510(k) K113068 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AUTO A-FLEX HT
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Oct 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2024 | Philips Respironics, Inc. OmniLab Advanced + Ventilator
Product Numbers
1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 Open, Classified |
MNS | 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.