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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K053083
Device Name DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
Applicant
Datrix
340 State Place
Escondido,  CA  92029
Applicant Contact LINDA GLUCKMAN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/02/2005
Decision Date 11/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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