The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 2mp Color Lcd Monitor, Radiforce Mx215.
| Device ID | K131090 |
| 510k Number | K131090 |
| Device Name: | 2MP COLOR LCD MONITOR, RADIFORCE MX215 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO CORPORATION 153 SHIMOKASHIWANO Hakusan, Ishikawa, JP 924-8566 |
| Contact | Hiroaki Hashimoto |
| Correspondent | Hiroaki Hashimoto EIZO 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 | 2013-04-18 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047049456 | K131090 | 000 |
| 04995047042419 | K131090 | 000 |