OXYLOG 3000
FDA 510(k) clearance K062267 · decided 2006-10-31
Clearance details
- K-number
- K062267
- Device name
- OXYLOG 3000
- Applicant
- Drager Medical B.V.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-04
- Decision date
- 2006-10-31
- Days to decision
- 88 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, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Ox recall (Z-2215-2016) | Draeger Medical, Inc. | 2016-08-04 |
| 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 |
| Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 31 recall (Z-0018-2011) | Draeger Medical Systems, Inc. | 2010-10-07 |
| Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version recall (Z-0202-2009) | Draeger Medical, Inc. | 2008-10-27 |