Clearance Summary
ELECTRO-PULSE received FDA 510(k) clearance under submission number K832160, sponsored by Electro-Pulse. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1983-11-14.
- Submission: K832160
- Applicant / Sponsor: Electro-Pulse
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1983-11-14
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.