The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for Md21m 21.3 Diagnostic Imaging Lcd Monitor, Model L218tk.
| Device ID | K083332 |
| 510k Number | K083332 |
| Device Name: | MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK |
| Classification | System, Image Processing, Radiological |
| Applicant | NEC DISPLAY SOLUTIONS, LTD. 1F, NO. 181, SEC. 2 WUNHUA 1ST ROAD, LINKOU TOWNSHIP Taipe, TW 244 |
| Contact | Angus Hsu |
| Correspondent | Angus Hsu NEC DISPLAY SOLUTIONS, LTD. 1F, NO. 181, SEC. 2 WUNHUA 1ST ROAD, LINKOU TOWNSHIP Taipe, TW 244 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-01-09 |
| Summary: | summary |