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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K970951
Device Name GRASS BRAINWAVE SOFTWARE
Applicant
ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK,  RI  02893
Applicant Contact STEPHEN E JOHNSON
Correspondent
ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK,  RI  02893
Correspondent Contact STEPHEN E JOHNSON
Regulation Number882.1400
Classification Product Code
OLV  
Date Received03/14/1997
Decision Date 05/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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