Capno Module, 92517
FDA 510(k) K130112 · Spacelabs Healthcare
510(k) numberK130112
Submission
- Device name
- Capno Module, 92517
- Applicant
- Spacelabs Healthcare
Nederland, CO, US - Received
- January 16, 2013
- Decision date
- March 21, 2013
- 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 Capno Module, 92517 cleared by the FDA?
Capno Module, 92517 (K130112) received a 510(k) decision of Substantially Equivalent on March 21, 2013, 64 days after the submission was received.
What is the product code of K130112?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.