Clearance Summary
MANTRA ELECTRODE received FDA 510(k) clearance under submission number K041902, sponsored by Mantra Intl. (Hk) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-09-22.
- Submission: K041902
- Applicant / Sponsor: Mantra Intl. (Hk) , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2004-09-22
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.