The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Digital Science 9000d Medical Laser Printer (9000d).
Device ID | K972847 |
510k Number | K972847 |
Device Name: | KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) |
Classification | Camera, Multi Format, Radiological |
Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Contact | Robert L Hiller |
Correspondent | Robert L Hiller EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -0002 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-01 |
Decision Date | 1997-10-07 |
Summary: | summary |