NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
FDA 510(k) clearance K010093 · decided 2001-06-14
Clearance details
- K-number
- K010093
- Device name
- NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
- Applicant
- Drager Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2001-01-11
- Decision date
- 2001-06-14
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Evita 2 dura Critical Care Ventilator. Continuous (Respirator) recall (Z-2325-2008) | Draeger Medical, Inc. | 2008-09-20 |
| Evita 4 Critical Care Ventilator. Continuous (Respirator) recall (Z-2326-2008) | Draeger Medical, Inc. | 2008-09-20 |
| Evita 4 Continuous Ventilator recall (Z-0954-03) | Draeger Medical, Inc. | 2003-06-27 |