The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for 4mp Color Lcd Monitor, Radiforcerx430.
Device ID | K112466 |
510k Number | K112466 |
Device Name: | 4MP COLOR LCD MONITOR, RADIFORCERX430 |
Classification | System, Image Processing, Radiological |
Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO, HAKUSAN Ishikawa, JP 924-8566 |
Contact | Hiroaki Hashimoto |
Correspondent | Hiroaki Hashimoto EIZO NANAO 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 | 2011-08-26 |
Decision Date | 2011-10-27 |
Summary: | summary |