Clearance Summary
ACCU-TRODE (DISP. ECG ELECTRODE) received FDA 510(k) clearance under submission number K771392, sponsored by Warner/Chilcott. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1977-08-16.
- Submission: K771392
- Applicant / Sponsor: Warner/Chilcott
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1977-08-16
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.