Infinity Mcable - Mainstream CO2
FDA 510(k) K100941 · Draeger Medical AG & Co. KG
510(k) numberK100941
Submission
- Device name
- Infinity Mcable - Mainstream CO2
- Applicant
- Draeger Medical AG & Co. KG
Lubeck, DE - Received
- April 5, 2010
- Decision date
- April 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Infinity Mcable - Mainstream CO2 cleared by the FDA?
Infinity Mcable - Mainstream CO2 (K100941) received a 510(k) decision of Substantially Equivalent on April 23, 2010, 18 days after the submission was received.
What is the product code of K100941?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.