CO2 Mainstream Sensor
FDA 510(k) K221118 · Draegerwerk AG & CO Kgaa
510(k) numberK221118
Submission
- Device name
- CO2 Mainstream Sensor
- Applicant
- Draegerwerk AG & CO Kgaa
Luebeck, DE - Received
- April 18, 2022
- Decision date
- April 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was CO2 Mainstream Sensor cleared by the FDA?
CO2 Mainstream Sensor (K221118) received a 510(k) decision of Substantially Equivalent on April 5, 2023, 352 days after the submission was received.
What is the product code of K221118?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.