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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 K050425
Device Name AURA-PSG
Applicant
ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK,  RI  02893
Applicant Contact MICHAEL J SULLIVAN
Correspondent
ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK,  RI  02893
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number882.1400
Classification Product Code
OLV  
Date Received02/18/2005
Decision Date 10/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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