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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 K161976
Device Name Ziehm Solo FD
Applicant
Ziehm Imaging GmbH
Donaustrasse 31
Nuremberg,  DE D-90451
Applicant Contact RICHARD L. WESTRICH
Correspondent
Ziehm Imaging, Inc.
6280 Hazeltine National Dr.
Orlando,  FL  32822
Correspondent Contact RICHARD L. WESTRICH
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received07/18/2016
Decision Date 10/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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