FDA 510(k) Application Details - K020449

Device Classification Name System, Image Processing, Radiological

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510(K) Number K020449
Device Name System, Image Processing, Radiological
Applicant CARDIONOW, INC.
535 ENCINITAS BLVD., SUITE 118
ENCINITAS, CA 92024 US
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Contact JOHNNY M GARZA
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 02/11/2002
Decision Date 05/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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