The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science-dental Image Viewer.
Device ID | K973476 |
510k Number | K973476 |
Device Name: | KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Contact | Judith A Wallace |
Correspondent | Judith A Wallace EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-15 |
Decision Date | 1997-11-10 |
Summary: | summary |