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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 K093583
Device Name EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
Applicant
ST. JUDE MEDICAL
575 ROUTE 73 N
BUILDING D
WEST BERLIN,  NJ  08901
Applicant Contact TIM KAPPERS
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/19/2009
Decision Date 12/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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