OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
FDA 510(k) clearance K103625 · decided 2011-10-06
Clearance details
- K-number
- K103625
- Device name
- OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-10
- Decision date
- 2011-10-06
- Days to decision
- 300 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 |
|---|---|---|
| Oxylog 3000 Plus emergency and transport ventilator recall (Z-2018-2023) | Draeger Medical, Inc. | 2023-07-08 |
| 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 |
| Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 570 recall (Z-1440-2014) | Draeger Medical Systems, Inc. | 2014-04-10 |