The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan, Xlt7720, Xlt7700, Pcd 2000.
Device ID | K922411 |
510k Number | K922411 |
Device Name: | KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 |
Classification | Camera, Multi Format, 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 | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-21 |
Decision Date | 1992-08-24 |