OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
FDA 510(k) clearance K082600 · decided 2008-11-26
Clearance details
- K-number
- K082600
- Device name
- OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
- Applicant
- Draeger Medical B.V.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-08
- Decision date
- 2008-11-26
- Days to decision
- 79 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 |
|---|---|---|
| Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume recall (Z-0691-2016) | Draeger Medical, Inc. | 2016-02-03 |
| Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Cata recall (Z-0692-2016) | Draeger Medical, Inc. | 2016-02-03 |