OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE— 510(k) K103625
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K103625 for OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE, Substantially Equivalent on 2011-10-06. Applicant: Draeger Medical Systems, Inc..
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- 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.