510(k) K090248 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP AUTOSV
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 4, 2009 |
| Received | Feb 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2022 | Philips Respironics, Inc. Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | None listed |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | None listed |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | None listed |
| Jul 13, 2021 | Philips Respironics, Inc. DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting
The Philips Respironics E30 ventilator is Open, Classified |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.