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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 K972996
Device Name EASY ECG PC BASED ELECTROCARDIOGRAPH
Applicant
Ates Medical S.R.L.
15700 Devonshire St.
Granada Hills,  CA  91344
Applicant Contact MICHAEL DAVIDSON
Correspondent
Ates Medical S.R.L.
15700 Devonshire St.
Granada Hills,  CA  91344
Correspondent Contact MICHAEL DAVIDSON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/12/1997
Decision Date 04/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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