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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 K160840
Device Name ECG100+, ECG200+
Applicant
Cardioline S.P.A
Via Linz 19/20/21
Spini Di Gardolo,  IT 38121
Applicant Contact EMANUELE ERCOLI
Correspondent
Studio Technico Ing. Peluso
Via Prati 1/2
Zola Predosa-Localita Ponte Ronca-Bologn,  IT 40069
Correspondent Contact ALESSANDRO PELUSO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/28/2016
Decision Date 08/12/2016
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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