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 Hd-25 Lasr Imager.
Device ID | K923042 |
510k Number | K923042 |
Device Name: | DU PONT LINX HD-25 LASR IMAGER |
Classification | System, Image Processing, Radiological |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Richard M Forbis |
Correspondent | Richard M Forbis E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-24 |
Decision Date | 1992-11-09 |