Clearance Summary
EASY READ(TM) received FDA 510(k) clearance under submission number K871794, sponsored by Health O Meter. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-06-19.
- Submission: K871794
- Applicant / Sponsor: Health O Meter
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1987-06-19
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.