The following data is part of a premarket notification filed by Kodak Health Imaging Systems, Inc. with the FDA for Kodak Digital Science Medical Printer Interface Unit.
Device ID | K961740 |
510k Number | K961740 |
Device Name: | KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT |
Classification | System, Image Processing, Radiological |
Applicant | KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
Contact | Nancy Butcher |
Correspondent | Nancy Butcher KODAK HEALTH IMAGING SYSTEMS, INC. 18325 WATERVIEW PKWY. Dallas, TX 75252 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-03 |
Decision Date | 1996-11-14 |
Summary: | summary |