SIEMENS-ELEMA AB CO2 MONITOR 130— 510(k) K802459
Substantially EquivalentSiemens Elema AB
FDA 510(k) clearance K802459 for SIEMENS-ELEMA AB CO2 MONITOR 130, Substantially Equivalent on 1980-10-23. Applicant: Siemens Elema AB. Device class: 2.
Clearance details
- Applicant
- Siemens Elema AB
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code CCK
view allMore clearances from Siemens Elema AB
view allAdverse 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.