VIZTEK DR, MODELS: DR1000, DR3000, DR4000

System, X-ray, Stationary

VIZTEK, INC.

The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Viztek Dr, Models: Dr1000, Dr3000, Dr4000.

Pre-market Notification Details

Device IDK082604
510k NumberK082604
Device Name:VIZTEK DR, MODELS: DR1000, DR3000, DR4000
ClassificationSystem, X-ray, Stationary
Applicant VIZTEK, INC. PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
VIZTEK, INC. PO BOX 7007 Deerfield,  IL  60015
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-08
Decision Date2008-11-21
Summary:summary

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