meddevicedb.com FDA Device Reference

XLTEK CONNEX IP HEADBOX, MODEL 1054

K042223 Class II Special
Decision Date
2004-09-16
Sponsor / Applicant
Excel Tech. , Ltd.

Technical Specification

510(k) Submission ID K042223
Product Code OMB
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1400
Decision Date 2004-09-16
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

XLTEK CONNEX IP HEADBOX, MODEL 1054 received FDA 510(k) clearance under submission number K042223, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-09-16.

Classification & Regulation

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