Clearance Summary
DIGITAL ELECTRONIC B.P. MONITOR 2155 received FDA 510(k) clearance under submission number K800778, 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 1980-04-29.
- Submission: K800778
- Applicant / Sponsor: Sears, Roebuck & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1980-04-29
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.