EVITAXL WITH OPTION SMARTCARE
FDA 510(k) clearance K051263 · decided 2005-07-12
Clearance details
- K-number
- K051263
- Device name
- EVITAXL WITH OPTION SMARTCARE
- Applicant
- Drager Medical AG & Co. Kgaa
- Decision
- Substantially Equivalent
- Date received
- 2005-05-16
- Decision date
- 2005-07-12
- Days to decision
- 57 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 XL Critical Care Ventilator. Continuous (Respirator) recall (Z-2327-2008) | Draeger Medical, Inc. | 2008-09-20 |