The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for 5mp Monochrome Lcd Monitor, Radiforce Gx540.
| Device ID | K130336 |
| 510k Number | K130336 |
| Device Name: | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO, HAKUSAN Ishikawa, JP 924-8566 |
| Contact | Hiroaki Hashimoto |
| Correspondent | Hiroaki Hashimoto EIZO NANAO CORPORATION 153 SHIMOKASHIWANO, HAKUSAN Ishikawa, JP 924-8566 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-03-28 |
| Summary: | summary |