The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Linx Laser Imager W/the Linx Networking.
Device ID | K900935 |
510k Number | K900935 |
Device Name: | DU PONT LINX LASER IMAGER W/THE LINX NETWORKING |
Classification | System, Digital Image Communications, Radiological |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Kenneth L Woodlin |
Correspondent | Kenneth L Woodlin E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-28 |
Decision Date | 1990-05-15 |