The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for 21.3 Inch Monochrome Lcd Monitor.
| Device ID | K061947 |
| 510k Number | K061947 |
| Device Name: | 21.3 INCH MONOCHROME LCD MONITOR |
| 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 | Tamas Borsai 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 | 2006-07-10 |
| Decision Date | 2006-07-25 |
| Summary: | summary |