Clearance Summary
ELECTRODE BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K810635, sponsored by Sears, Roebuck & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-05-08.
- Submission: K810635
- Applicant / Sponsor: Sears, Roebuck & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1981-05-08
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.