Softech Plus ETC02 Cannula
FDA 510(k) K132946 · Teleflexmedical, Inc.
510(k) numberK132946
Submission
- Device name
- Softech Plus ETC02 Cannula
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- September 19, 2013
- Decision date
- June 4, 2014
- 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 Softech Plus ETC02 Cannula cleared by the FDA?
Softech Plus ETC02 Cannula (K132946) received a 510(k) decision of Substantially Equivalent on June 4, 2014, 258 days after the submission was received.
What is the product code of K132946?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.