AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER

Unit, X-ray, Intraoral

CHICAGO X-RAY SYSTEMS, INC.

The following data is part of a premarket notification filed by Chicago X-ray Systems, Inc. with the FDA for Aztech 65 With Ccd (computer Controlled Density) Timer.

Pre-market Notification Details

Device IDK950667
510k NumberK950667
Device Name:AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
ClassificationUnit, X-ray, Intraoral
Applicant CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling,  IL  60090
ContactAl Sosa
CorrespondentAl Sosa
CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling,  IL  60090
Product CodeEAP  
CFR Regulation Number872.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-13
Decision Date1995-04-06

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