Clearance Summary
SPHYGMOMANOMETER #1235 received FDA 510(k) clearance under submission number K771666, 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 1977-09-30.
- Submission: K771666
- Applicant / Sponsor: Sears, Roebuck & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1977-09-30
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.