ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM

Interventional Fluoroscopic X-ray System

ZIEHM IMAGING, INC.

The following data is part of a premarket notification filed by Ziehm Imaging, Inc. with the FDA for Ziehm Vision Fd Digital Mobile Imaging System.

Pre-market Notification Details

Device IDK061534
510k NumberK061534
Device Name:ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
ClassificationInterventional Fluoroscopic X-ray System
Applicant ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside,  CA  92501
ContactRichard Westrich
CorrespondentRichard Westrich
ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside,  CA  92501
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-02
Decision Date2006-07-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.