The following data is part of a premarket notification filed by Chi Lin Technology Co., Ltd. with the FDA for 2mp Medical Monochrome Reference Display, Model Mdm2130-2nc.
| Device ID | K063289 |
| 510k Number | K063289 |
| Device Name: | 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC |
| Classification | System, Image Processing, Radiological |
| Applicant | CHI LIN TECHNOLOGY CO., LTD. 3F, # 86, SEC 1 WUNHUA 1ST RD. Linkuo, Taipei Hsien, TW 244 |
| Contact | Judy Lin |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2006-11-16 |
| Summary: | summary |