The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for 2mp Monochrome Lcd Monitor, Radiforce Gx240.
| Device ID | K120407 |
| 510k Number | K120407 |
| Device Name: | 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO Hakusan, JP 924-8566 |
| Contact | Hiroaki Hashimoto |
| Correspondent | Hiroaki Hashimoto EIZO NANAO CORPORATION 153 SHIMOKASHIWANO Hakusan, 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 | 2012-02-09 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14995047040214 | K120407 | 000 |
| 04995047040194 | K120407 | 000 |
| 14995047061219 | K120407 | 000 |
| 04995047061168 | K120407 | 000 |