KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)

System, Digital Image Communications, Radiological

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Imagelink System (keis).

Pre-market Notification Details

Device IDK931551
510k NumberK931551
Device Name:KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
ClassificationSystem, Digital Image Communications, Radiological
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 CodeLMD  
CFR Regulation Number892.2020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-29
Decision Date1993-06-29

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