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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K071364
Device Name MICROTARGETING GUIDELINE 4000
Applicant
FHC, INC.
1201 MAIN ST
BOWDOIN,  ME  04287
Applicant Contact LEE D MARGOLIN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number882.1330
Classification Product Code
GZL  
Date Received05/16/2007
Decision Date 07/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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