Clearance Summary
APPRAISE-HRI received FDA 510(k) clearance under submission number K233249, sponsored by The Surgeon General, Department of the Army (TSG-DA). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-04-05.
- Submission: K233249
- Applicant / Sponsor: The Surgeon General, Department of the Army (TSG-DA)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2220
- Decision date: 2024-04-05
Classification & Regulation
This clearance is catalogued under FDA product code SAR and 21 CFR 870.2220, within the Cardiovascular review panel as a Class II device.