K100941
Substantially EquivalentINFINITY MCABLE - MAINSTREAM CO2
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lubeck, DE
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.