Clearance Summary
FaceHeart Vitals Software Development Kit (FH vitals SDK) received FDA 510(k) clearance under submission number K223622, sponsored by Faceheart Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-09-01.
- Submission: K223622
- Applicant / Sponsor: Faceheart Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2785
- Decision date: 2023-09-01
Classification & Regulation
This clearance is catalogued under FDA product code QME and 21 CFR 870.2785, within the Cardiovascular review panel as a Class II device.