FDA 510(k) Application Details - K954875

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K954875
Device Name Digitizer, Image, Radiological
Applicant ASPECT ELECTRONICS, INC.
16303 PANORAMIC WAY
SAN LEANDRO, CA 94578-1116 US
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Contact GARY J ALLSEBROOK
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 10/24/1995
Decision Date 01/02/1996
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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