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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K914571
Device Name NEUROTRAC II
Applicant
Moberg Medical, Inc.
11o W. Butler Ave.
Ambler,  PA  19002
Applicant Contact RICHARD MOBERG
Correspondent
Moberg Medical, Inc.
11o W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact RICHARD MOBERG
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received10/15/1991
Decision Date 01/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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