FDA 510(k) Application Details - K031638

Device Classification Name System, Image Processing, Radiological

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510(K) Number K031638
Device Name System, Image Processing, Radiological
Applicant ELECTROMED IMAGING INC.
440 ARMAND-FRAPPIER BLVD.,#250
LAVAL, QUEBEC H7V 4B4 CA
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Contact WARREN BAKER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/27/2003
Decision Date 07/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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