Clearance Summary
ELECTRO-CAP SYSTEM received FDA 510(k) clearance under submission number K112319, sponsored by Electro-Cap Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-01-27.
- Submission: K112319
- Applicant / Sponsor: Electro-Cap Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2012-01-27
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.