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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 K101331
Device Name LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
Applicant
C.R. Bard Inc., Bard Electrophysiology Division
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact ANASTASIA C RANDALL
Correspondent
C.R. Bard Inc., Bard Electrophysiology Division
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact ANASTASIA C RANDALL
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/11/2010
Decision Date 10/08/2010
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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