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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K974351
Device Name BIOLOG 3000 ELECTROCARDIOGRAPH
Applicant
MICROMEDICAL, INC.
255 REVERE DR., SUITE 111
NORTHBROOK,  IL  60062
Applicant Contact MALCOM CASTLE
Correspondent
MICROMEDICAL, INC.
255 REVERE DR., SUITE 111
NORTHBROOK,  IL  60062
Correspondent Contact MALCOM CASTLE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/19/1997
Decision Date 04/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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