The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omat 5000 Ra Processor.
Device ID | K951397 |
510k Number | K951397 |
Device Name: | KODAK X-OMAT 5000 RA PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Contact | William B Wilson |
Correspondent | William B Wilson EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-27 |
Decision Date | 1995-05-15 |