FDA 510(k) Application Details - K103724

Device Classification Name System, Image Processing, Radiological

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510(K) Number K103724
Device Name System, Image Processing, Radiological
Applicant EIZO GMBH
SIEMENSALLEE 84
KARLSRUHE 76187 DE
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Contact GUENTER M VOLZ
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/21/2010
Decision Date 06/08/2011
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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