The following data is part of a premarket notification filed by Summit Industries, Inc. with the FDA for C900 X-ray Film Processor.
Device ID | K874908 |
510k Number | K874908 |
Device Name: | C900 X-RAY FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
Contact | Jim Walsh |
Correspondent | Jim Walsh SUMMIT INDUSTRIES, INC. 2901 WEST LAWRENCE AVE. Chicago, IL 60625 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1988-02-12 |