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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K880977
Device Name ADR-2000 AMBULATORY DATA RECORDING SYSTEM
Applicant
AARON LABORATORIES, INC.
P.O. BOX 29264
SAN ANTONIO,  TX  78229
Applicant Contact CHARLES G BURGAR,MD
Correspondent
AARON LABORATORIES, INC.
P.O. BOX 29264
SAN ANTONIO,  TX  78229
Correspondent Contact CHARLES G BURGAR,MD
Regulation Number890.1375
Classification Product Code
IKN  
Date Received03/08/1988
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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