The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Xlp Preliminary Dv2000 Interface.
Device ID | K912454 |
510k Number | K912454 |
Device Name: | KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE |
Classification | System, X-ray, Tomography, Computed |
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 | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-03 |
Decision Date | 1991-09-27 |