Clearance Summary
FRANTZ MEDICAL ELECTRODE received FDA 510(k) clearance under submission number K863508, sponsored by Frantz Medical Development, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-02-06.
- Submission: K863508
- Applicant / Sponsor: Frantz Medical Development, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2320
- Decision date: 1987-02-06
Classification & Regulation
This clearance is catalogued under FDA product code DXR and 21 CFR 870.2320, within the Cardiovascular review panel as a Class II device.