The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for 4mp Color Lcd Monitor, Radiforce Rx440.
| Device ID | K130070 |
| 510k Number | K130070 |
| Device Name: | 4MP COLOR LCD MONITOR, RADIFORCE RX440 |
| 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 | 2013-01-11 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04995047041788 | K130070 | 000 |