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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 K052295
Device Name CARDIOSOFT PC ECG, USB VERSION
Applicant
Cardiosoft, L.P.
1776 Yorktown, Suite Ll-30
Houston,  TX  77056
Applicant Contact S. MORADI
Correspondent
Cardiosoft, L.P.
1776 Yorktown, Suite Ll-30
Houston,  TX  77056
Correspondent Contact S. MORADI
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/23/2005
Decision Date 01/13/2006
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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