Clearance Summary
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES received FDA 510(k) clearance under submission number K931724, sponsored by Continental X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-06-14.
- Submission: K931724
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1993-06-14
Classification & Regulation
This clearance is catalogued under FDA product code KXJ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.