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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 K033978
Device Name ADAM
Applicant
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Applicant Contact MICHAEL J SULLIVAN
Correspondent
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/23/2003
Decision Date 02/18/2004
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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