Clearance Summary
GERARD MEDICAL ELECTRODE TESTER received FDA 510(k) clearance under submission number K813358, sponsored by Gerard Medical Enterprises, 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 1981-12-29.
- Submission: K813358
- Applicant / Sponsor: Gerard Medical Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2370
- Decision date: 1981-12-29
Classification & Regulation
This clearance is catalogued under FDA product code KRC and 21 CFR 870.2370, within the Cardiovascular review panel as a Class II device.