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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 K852770
Device Name CARIOLINE(ELECTROCARDIOGRAPH)
Applicant
Remco Italia S.P.A.
20060 S. Pedrino Di Vignate
Milano, Italia(Italy),  IT
Applicant Contact RIVOLTANA NUO
Correspondent
Remco Italia S.P.A.
20060 S. Pedrino Di Vignate
Milano, Italia(Italy),  IT
Correspondent Contact RIVOLTANA NUO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/28/1985
Decision Date 08/01/1985
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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