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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 K002597
Device Name CN ACQUISITION STATION
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 Received08/21/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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