The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Cp Primary High Freq. Vid.interface.
Device ID | K925721 |
510k Number | K925721 |
Device Name: | KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE |
Classification | Digitizer, Image, Radiological |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Samuel Consol |
Correspondent | Samuel Consol EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | LMA |
CFR Regulation Number | 892.2030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-12 |
Decision Date | 1993-02-26 |