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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 K141185
Device Name V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
Applicant
Boston Scientific Corp
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact ROBIN MULVEY
Correspondent
Boston Scientific Corp
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact ROBIN MULVEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/07/2014
Decision Date 06/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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