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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K020449
Device Name CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
Applicant
Cardionow, Inc.
535 Encinitas Blvd., Suite 118
Encinitas,  CA  92024
Applicant Contact JOHNNY M GARZA
Correspondent
Cardionow, Inc.
535 Encinitas Blvd., Suite 118
Encinitas,  CA  92024
Correspondent Contact JOHNNY M GARZA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/11/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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