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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 K031000
Device Name LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
Applicant
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Applicant Contact DEBORAH L HERRINGTON
Correspondent
C.R. Bard, Inc.
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact DEBORAH L HERRINGTON
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/31/2003
Decision Date 06/03/2003
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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