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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K043009
Device Name BRAINET KIT
Applicant
Jordan Neuroscience, Inc.
399 E. Highland Ave., Suite 316
San Bernardino,  CA  92404
Applicant Contact ANNE PERRY
Correspondent
Jordan Neuroscience, Inc.
399 E. Highland Ave., Suite 316
San Bernardino,  CA  92404
Correspondent Contact ANNE PERRY
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GXZ  
Date Received11/01/2004
Decision Date 01/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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