The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science Remote Cassette.
Device ID | K962896 |
510k Number | K962896 |
Device Name: | KODAK DIGITAL SCIENCE REMOTE CASSETTE |
Classification | System, X-ray, Stationary |
Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Contact | John Le Clair |
Correspondent | John Le Clair EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-25 |
Decision Date | 1996-09-20 |
Summary: | summary |