FDA 510(k) Application Details - K972701

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K972701
Device Name System, Digital Image Communications, Radiological
Applicant BARCO NV DISPLAY SYSTEMS
3407 BAY AVE.
CHICO, CA 95973 US
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Contact FRANK FERGUSON
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 07/18/1997
Decision Date 01/02/1998
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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