The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektascan Network Interface/for Other Manufacturers.
Device ID | K936116 |
510k Number | K936116 |
Device Name: | KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS |
Classification | System, Digital Image Communications, Radiological |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Contact | Norman H Geil |
Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-23 |
Decision Date | 1994-04-29 |