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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K192438
Device Name Rhythmia HDxTM Mapping System
Applicant
Boston Scientific Corporation
125 Cambridge Park Dr.
Cambridge,  MA  02140
Applicant Contact Lee Margolin
Correspondent
Boston Scientific Corporation
125 Cambridge Park Dr.
Cambridge,  MA  02140
Correspondent Contact Lee Margolin
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/06/2019
Decision Date 11/27/2019
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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