FDA 510(k) Application Details - K190497

Device Classification Name

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510(K) Number K190497
Device Name Ziehm 8000
Applicant Ziehm Imaging GmbH
Donaustrasse 31
Nuremberg 90451 DE
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Contact Steve Seeman
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Regulation Number

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Classification Product Code OWB
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Date Received 02/28/2019
Decision Date 11/20/2019
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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