The following data is part of a premarket notification filed by Eizo Gmbh with the FDA for 10 Mp Grayscale Flat Panel Display (gx 1030).
Device ID | K103724 |
510k Number | K103724 |
Device Name: | 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) |
Classification | System, Image Processing, Radiological |
Applicant | EIZO GMBH SIEMENSALLEE 84 Karlsruhe, DE 76187 |
Contact | Guenter M Volz |
Correspondent | Guenter M Volz EIZO GMBH SIEMENSALLEE 84 Karlsruhe, DE 76187 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-21 |
Decision Date | 2011-06-08 |
Summary: | summary |