The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science Pro-medical Thermal Printer.
Device ID | K971973 |
510k Number | K971973 |
Device Name: | KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER |
Classification | System, Image Processing, Radiological |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Hermann Arndt |
Correspondent | Hermann Arndt EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-29 |
Decision Date | 1997-08-25 |