BIPAP A 40 VENTILATORY SUPPORT SYSTEM
FDA 510(k) clearance K121623 · decided 2012-12-14
Clearance details
- K-number
- K121623
- Device name
- BIPAP A 40 VENTILATORY SUPPORT SYSTEM
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-01
- Decision date
- 2012-12-14
- Days to decision
- 196 days
- Clearance type
- Abbreviated
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of t recall (Z-2037-2025) | Philips Respironics, Inc. | 2025-07-02 |
| OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111 recall (Z-1817-2024) | Philips Respironics, Inc. | 2024-05-23 |
| A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting recall (Z-1958-2021) | Philips Respironics, Inc. | 2021-07-15 |