CO2 Mainstream Sensor— 510(k) K221118
Substantially EquivalentDraegerwerk AG & CO Kgaa
FDA 510(k) clearance K221118 for CO2 Mainstream Sensor, Substantially Equivalent on 2023-04-05. Applicant: Draegerwerk AG & CO Kgaa.
Clearance details
- Applicant
- Draegerwerk AG & CO Kgaa
- Product code
- Code CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, 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.