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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 K010822
Device Name AB CARDIETTE START 200 HV
Applicant
H&C Medical Devices Spa
Via Pisa 250
20099 Sesto San Giovanni
Milan,  IT
Applicant Contact ATTILIO CASTELLI
Correspondent
H&C Medical Devices Spa
Via Pisa 250
20099 Sesto San Giovanni
Milan,  IT
Correspondent Contact ATTILIO CASTELLI
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/19/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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