The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 6mp Color Lcd Monitor, Radiforce Rx650.
| Device ID | K134002 |
| 510k Number | K134002 |
| Device Name: | 6MP COLOR LCD MONITOR, RADIFORCE RX650 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO CORPORATION 153 SHIMOKASHIWANO Hakusan, Ishikawa, JP 924-8566 |
| Contact | Toshimine Hiraki |
| Correspondent | Toshimine Hiraki 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 | 2013-12-27 |
| Decision Date | 2014-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047046202 | K134002 | 000 |
| 04995047044178 | K134002 | 000 |