AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
FDA 510(k) K230915 · Vyaire Medical, Inc.
510(k) numberK230915
Submission
- Device name
- AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
- Applicant
- Vyaire Medical, Inc.
Mettawa, IL, US - Received
- March 31, 2023
- Decision date
- November 12, 2024
- 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 AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask cleared by the FDA?
AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask (K230915) received a 510(k) decision of Substantially Equivalent on November 12, 2024, 592 days after the submission was received.
What is the product code of K230915?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.