CO2 monitoring line with and without in-line filter
FDA 510(k) K143150 · Besmed Health Business Corp
510(k) numberK143150
Submission
- Device name
- CO2 monitoring line with and without in-line filter
- Applicant
- Besmed Health Business Corp
New Taipei City, TW - Received
- November 3, 2014
- Decision date
- February 5, 2015
- 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 monitoring line with and without in-line filter cleared by the FDA?
CO2 monitoring line with and without in-line filter (K143150) received a 510(k) decision of Substantially Equivalent on February 5, 2015, 94 days after the submission was received.
What is the product code of K143150?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.