The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omat Model 180 Lp Processor.
Device ID | K921269 |
510k Number | K921269 |
Device Name: | KODAK X-OMAT MODEL 180 LP PROCESSOR |
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 | 1992-03-17 |
Decision Date | 1992-05-01 |