The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan.
Device ID | K923554 |
510k Number | K923554 |
Device Name: | KODAK EKTASCAN |
Classification | Processor, Radiographic-film, Automatic |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-17 |
Decision Date | 1993-02-12 |