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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 K190497
Device Name Ziehm 8000
Applicant
Ziehm Imaging GmbH
Donaustrasse 31
Nuremberg,  DE 90451
Applicant Contact Steve Seeman
Correspondent
Ziehm Imaging, Inc.
6280 Hazeltine National Drive
Orlando,  FL  32822
Correspondent Contact Steve Seeman
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received02/28/2019
Decision Date 11/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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