BIPAP AUTOSV
FDA 510(k) clearance K090248 · decided 2009-03-04
Clearance details
- K-number
- K090248
- Device name
- BIPAP AUTOSV
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Decision
- Substantially Equivalent
- Date received
- 2009-02-02
- Decision date
- 2009-03-04
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MNS
- 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
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|---|---|---|
| Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with o recall (Z-1655-2022) | Philips Respironics, Inc. | 2022-09-09 |
| Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patient recall (Z-1657-2022) | Philips Respironics, Inc. | 2022-09-09 |
| Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ve recall (Z-1659-2022) | Philips Respironics, Inc. | 2022-09-09 |
| DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and A recall (Z-1973-2021) | Philips Respironics, Inc. | 2021-07-13 |