The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for Monochrome Lcd Monitor, Radiforce, Gs320.
Device ID | K062053 |
510k Number | K062053 |
Device Name: | MONOCHROME LCD MONITOR, RADIFORCE, GS320 |
Classification | System, Image Processing, Radiological |
Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO-CHO MATTO-SHI Ishikawa-ken, JP 924-8566 |
Contact | Hiroaki Hashimoto |
Correspondent | Hiroaki Hashimoto EIZO NANAO CORPORATION 153 SHIMOKASHIWANO-CHO MATTO-SHI 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 | 2006-07-20 |
Decision Date | 2006-08-07 |
Summary: | summary |