Clearance Summary
AeviceMD received FDA 510(k) clearance under submission number K223382, sponsored by Aevice Health Pte. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-07-07.
- Submission: K223382
- Applicant / Sponsor: Aevice Health Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2023-07-07
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.