Clearance Summary
VER-MED A10014 RESTING EKG ELECTRODE & A10021 received FDA 510(k) clearance under submission number K910139, sponsored by Vermont Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-08-15.
- Submission: K910139
- Applicant / Sponsor: Vermont Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1991-08-15
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.