Clearance Summary
800 ECG ELECTRODE received FDA 510(k) clearance under submission number K790507, sponsored by Simonsen & Weels Eftf.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-05-18.
- Submission: K790507
- Applicant / Sponsor: Simonsen & Weels Eftf.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1979-05-18
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.