Clearance Summary
VitaloJAK Clinic (Model 7100) received FDA 510(k) clearance under submission number K253293, sponsored by Vitalograph , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-12-03.
- Submission: K253293
- Applicant / Sponsor: Vitalograph , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2025-12-03
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.