The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for Monochrome Lcd Monitor, Model Radiforce Gx320.
Device ID | K070122 |
510k Number | K070122 |
Device Name: | MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 |
Classification | System, Image Processing, Radiological |
Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO-CHO Hakusan, Ishikawa-ken, JP 924-8566 |
Contact | Hiroaki Hashimoto |
Correspondent | Hiroaki Hashimoto EIZO NANAO CORPORATION 153 SHIMOKASHIWANO-CHO Hakusan, Ishikawa-ken, JP 924-8566 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-16 |
Decision Date | 2007-02-08 |
Summary: | summary |