PERSONAL DISPLAY SYSTEM

System, Image Processing, Radiological

VORTECH DATA, INC.

The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Personal Display System.

Pre-market Notification Details

Device IDK924366
510k NumberK924366
Device Name:PERSONAL DISPLAY SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson,  TX  75080
ContactKem Myers
CorrespondentKem Myers
VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson,  TX  75080
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-28
Decision Date1993-04-07

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