SMART MOTORIZED VIEWER

Illuminator, Radiographic-film

SMARTLIGHT, LTD.

The following data is part of a premarket notification filed by Smartlight, Ltd. with the FDA for Smart Motorized Viewer.

Pre-market Notification Details

Device IDK973965
510k NumberK973965
Device Name:SMART MOTORIZED VIEWER
ClassificationIlluminator, Radiographic-film
Applicant SMARTLIGHT, LTD. 47 HATAASIYA ST. Nesher,  IL 36602
ContactDan Ben-zeev
CorrespondentDan Ben-zeev
SMARTLIGHT, LTD. 47 HATAASIYA ST. Nesher,  IL 36602
Product CodeIXC  
CFR Regulation Number892.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-17
Decision Date1997-12-12
Summary:summary

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