Clearance Summary
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE received FDA 510(k) clearance under submission number K823002, sponsored by Tri W-G, 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 1982-11-17.
- Submission: K823002
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1982-11-17
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.