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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K032276
Device Name CLICK HOLTER
Applicant
Remco Italia S.P.A.
Via Rivoltana Nuova 53
South Pedrino Di Vignate, Mi.,  IT 20060
Applicant Contact LUIGI BUCCHI
Correspondent
Remco Italia S.P.A.
Via Rivoltana Nuova 53
South Pedrino Di Vignate, Mi.,  IT 20060
Correspondent Contact LUIGI BUCCHI
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received07/23/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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