KODAK INSIGHT TWIN-LOAD INSERT

Screen, Intensifying, Radiographic

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Insight Twin-load Insert.

Pre-market Notification Details

Device IDK942909
510k NumberK942909
Device Name:KODAK INSIGHT TWIN-LOAD INSERT
ClassificationScreen, Intensifying, Radiographic
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactNorman H Geil
CorrespondentNorman H Geil
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeEAM  
CFR Regulation Number892.1960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-21
Decision Date1994-07-29

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