FDA 510(k) Application Details - K231701

Device Classification Name

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510(K) Number K231701
Device Name Ziehm Vision RFD 3D
Applicant Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg 90471 DE
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Contact Stefan Fiedler
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Regulation Number

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Classification Product Code OWB
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Date Received 06/12/2023
Decision Date 07/10/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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