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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K231669
Device Name Ziehm Solo FD
Applicant
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Applicant Contact Stefan Fiedler
Correspondent
Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
Nuremberg,  DE 90471
Correspondent Contact Tsvetelina Milanova
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/08/2023
Decision Date 12/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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