Clearance Summary
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE received FDA 510(k) clearance under submission number K983287, sponsored by Graphic Controls Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-11-05.
- Submission: K983287
- Applicant / Sponsor: Graphic Controls Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 1998-11-05
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.