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MACRO-MICRO DEPTH ELECTRODE

K041604 Class II Abbreviated
Decision Date
2004-08-16
Sponsor / Applicant
Ad-Tech Medical Instrument Corp

Technical Specification

510(k) Submission ID K041604
Product Code GZL
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1330
Decision Date 2004-08-16
Clearance Pathway Abbreviated

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MACRO-MICRO DEPTH ELECTRODE received FDA 510(k) clearance under submission number K041604, sponsored by Ad-Tech Medical Instrument Corp. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-08-16.

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.