The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for Medical Display, Md205mg-1.
| Device ID | K082493 |
| 510k Number | K082493 |
| Device Name: | MEDICAL DISPLAY, MD205MG-1 |
| Classification | System, Image Processing, Radiological |
| Applicant | NEC DISPLAY SOLUTIONS, LTD. 686-1 NISHIOI, OI-MACHI Ashigarakami-gun, Kanagawa, JP 258-8533 |
| Contact | Shuichi Kino |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-29 |
| Decision Date | 2008-10-23 |
| Summary: | summary |