The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for 3mp Monochrome Lcd Monitor, Radiforce Gx340.
| Device ID | K113784 |
| 510k Number | K113784 |
| Device Name: | 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO Iiakusan, JP 924-8566 |
| Contact | Hiroaki Hashimoto |
| Correspondent | Hiroaki Hashimoto EIZO NANAO CORPORATION 153 SHIMOKASHIWANO Iiakusan, 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 | 2011-12-22 |
| Decision Date | 2012-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14995047040252 | K113784 | 000 |
| 04995047040231 | K113784 | 000 |
| 14995047061110 | K113784 | 000 |
| 04995047061069 | K113784 | 000 |