Microstream CO2 NanoPod
FDA 510(k) K213911 · Covidien, LLC
510(k) numberK213911
Submission
- Device name
- Microstream CO2 NanoPod
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- December 15, 2021
- Decision date
- July 29, 2022
- 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 Microstream CO2 NanoPod cleared by the FDA?
Microstream CO2 NanoPod (K213911) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 226 days after the submission was received.
What is the product code of K213911?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.