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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K081551
Device Name TWIN NEUROTRAC-III
Applicant
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Applicant Contact ALFREDO BUSTAMANTE
Correspondent
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Correspondent Contact ALFREDO BUSTAMANTE
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   ORT  
Date Received06/03/2008
Decision Date 12/24/2008
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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