KODAK EKTASCAN

Processor, Radiographic-film, Automatic

EASTMAN KODAK COMPANY

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

Pre-market Notification Details

Device IDK923554
510k NumberK923554
Device Name:KODAK EKTASCAN
ClassificationProcessor, Radiographic-film, Automatic
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 CodeIXW  
CFR Regulation Number892.1900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-17
Decision Date1993-02-12

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