OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)— 510(k) K082600
Substantially EquivalentDraeger Medical B.V.
FDA 510(k) clearance K082600 for OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082), Substantially Equivalent on 2008-11-26. Applicant: Draeger Medical B.V..
Clearance details
- Applicant
- Draeger Medical B.V.
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.