The following data is part of a premarket notification filed by Eizo Nanao Corporation with the FDA for Eizo, Model Fc-2091.
| Device ID | K022109 |
| 510k Number | K022109 |
| Device Name: | EIZO, MODEL FC-2091 |
| Classification | System, Image Processing, Radiological |
| Applicant | EIZO NANAO CORPORATION 153 SHIMOKASHIWANO, MATTO Ishikawa 924-8566, JP |
| Contact | Yuuichi Seki |
| Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2002-07-12 |
| Summary: | summary |