Clearance Summary
Aevice Wheeze Detection Module received FDA 510(k) clearance under submission number K260140, sponsored by Aevice Health Pte. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-09-25.
- Submission: K260140
- Applicant / Sponsor: Aevice Health Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1900
- Decision date: 2026-09-25
Classification & Regulation
This clearance is catalogued under FDA product code PHZ and 21 CFR 868.1900, within the Anesthesiology review panel as a Class II device.