ZIEHM VISION RFD

System, X-ray, Fluoroscopic, Image-intensified

ZIEHM IMAGING GMBH

The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Vision Rfd.

Pre-market Notification Details

Device IDK132904
510k NumberK132904
Device Name:ZIEHM VISION RFD
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. Orlando,  FL  32822
ContactRichard L Westrich
CorrespondentRichard L Westrich
ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. Orlando,  FL  32822
Product CodeJAA  
Subsequent Product CodeOWB
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-16
Decision Date2013-12-05
Summary:summary

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