K230915
- 510(k) number
- K230915
- Device name
- AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
- Applicant
- Vyaire Medical, Inc. IL · US
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2024-11-12
- Date received
- 2023-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K230915.pdf
Official FDA record: K230915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.