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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 K902368
Device Name PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
Applicant
Esaote Biomedica Spa
C/O Parexel International Corp
One Alewife Pl.
Cambridge,  MA  02140
Applicant Contact BARRY SALL
Correspondent
Esaote Biomedica Spa
C/O Parexel International Corp
One Alewife Pl.
Cambridge,  MA  02140
Correspondent Contact BARRY SALL
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/29/1990
Decision Date 09/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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