The following data is part of a premarket notification filed by Eizo Gmbh with the FDA for 5mp Grayscale Flat Panel Display, Model, 6gf6201-5c$2# (where $ = A-z And # = 0-9).
Device ID | K081357 |
510k Number | K081357 |
Device Name: | 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) |
Classification | System, Image Processing, Radiological |
Applicant | EIZO GMBH SIEMENSALLEE 84 Karlsruhe, DE 76187 |
Contact | James Berge |
Correspondent | James Berge EIZO GMBH SIEMENSALLEE 84 Karlsruhe, DE 76187 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-14 |
Decision Date | 2008-09-05 |
Summary: | summary |