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WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

K001103 Class II Traditional
Decision Date
2000-06-30
Sponsor / Applicant
Excel Tech. , Ltd.

Technical Specification

510(k) Submission ID K001103
Product Code GWQ
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1400
Decision Date 2000-06-30
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) received FDA 510(k) clearance under submission number K001103, sponsored by Excel Tech. , 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 2000-06-30.

Classification & Regulation

This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.