FDA 510(k) Application Details - K203428

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

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510(K) Number K203428
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg 90471 DE
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Contact Stefan Fiedler
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Regulation Number 892.1650

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Classification Product Code JAA
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Date Received 11/20/2020
Decision Date 03/17/2021
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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