510(k) K090539 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP AUTOSV ADVANCED
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Oct 30, 2009 |
| Received | Feb 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090539
| 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 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.