BIPAP VISION VENTILATORY SUPPORT
FDA 510(k) clearance K982454 · decided 1998-11-03
Clearance details
- K-number
- K982454
- Device name
- BIPAP VISION VENTILATORY SUPPORT
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-07-15
- Decision date
- 1998-11-03
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electr recall (Z-1057-2008) | Respironics, Inc. | 2008-04-24 |
| Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk recall (Z-1085-2008) | Respironics, Inc. | 2008-04-24 |