510(k) K121623 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Jun 1, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K121623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | Philips Respironics, Inc. BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
BiPAP A40 Pro - sold OUS Open, Classified |
MNT | None listed |
| 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 15, 2021 | Philips Respironics, Inc. A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Open, Classified |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.