Dualguard
FDA 510(k) K140473 · Flexicare Medical, Ltd.
510(k) numberK140473
Submission
- Device name
- Dualguard
- Applicant
- Flexicare Medical, Ltd.
Mid Glamorgan, GB - Received
- February 25, 2014
- Decision date
- April 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Dualguard cleared by the FDA?
Dualguard (K140473) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 44 days after the submission was received.
What is the product code of K140473?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.