Clearance Summary
INTEL HEALTH GUIDE received FDA 510(k) clearance under submission number K103276, sponsored by Intel Corporation Digital Health Group. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-02-08.
- Submission: K103276
- Applicant / Sponsor: Intel Corporation Digital Health Group
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2011-02-08
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.