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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 K052883
Device Name CARDIOSERVER
Applicant
DATRIX
340 STATE PLACE
ESCONDIDO,  CA  92029
Applicant Contact LINDA GLUCKMAN
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 Received10/13/2005
Decision Date 11/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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