SOFTECH Plus ETCO2 Cannula
FDA 510(k) K143469 · Teleflexmedical, Inc.
510(k) numberK143469
Submission
- Device name
- SOFTECH Plus ETCO2 Cannula
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- December 5, 2014
- Decision date
- February 12, 2015
- 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 SOFTECH Plus ETCO2 Cannula cleared by the FDA?
SOFTECH Plus ETCO2 Cannula (K143469) received a 510(k) decision of Substantially Equivalent on February 12, 2015, 69 days after the submission was received.
What is the product code of K143469?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.