The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Imagelink System (keis).
Device ID | K931551 |
510k Number | K931551 |
Device Name: | KODAK EKTASCAN IMAGELINK SYSTEM (KEIS) |
Classification | System, Digital Image Communications, Radiological |
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 | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-29 |
Decision Date | 1993-06-29 |