Clearance Summary
WYLER SPHENOIDAL ELECTRODE received FDA 510(k) clearance under submission number K861031, sponsored by Ad-Tech Medical Instrument Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1986-08-25.
- Submission: K861031
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 1986-08-25
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.