Neo-Stat CO2 <Kg
FDA 510(k) K083056 · Mercury Medical
510(k) numberK083056
Submission
- Device name
- Neo-Stat CO2 <Kg
- Applicant
- Mercury Medical
Bonita Springs, FL, US - Received
- October 14, 2008
- Decision date
- February 23, 2009
- 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 Neo-Stat CO2 <Kg cleared by the FDA?
Neo-Stat CO2 <Kg (K083056) received a 510(k) decision of Substantially Equivalent on February 23, 2009, 132 days after the submission was received.
What is the product code of K083056?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.