The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for Monochrome Lcd Monitor, Radiforce Model Gs310.
| Device ID | K060845 |
| 510k Number | K060845 |
| Device Name: | MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 |
| 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 | 2006-03-28 |
| Decision Date | 2006-04-25 |
| Summary: | summary |