The following data is part of a premarket notification filed by Chilin Technology Co. Ltd with the FDA for Medical Display, Mdc1900-1lg (1lr).
| Device ID | K061305 |
| 510k Number | K061305 |
| Device Name: | MEDICAL DISPLAY, MDC1900-1LG (1LR) |
| Classification | System, Image Processing, Radiological |
| Applicant | CHILIN TECHNOLOGY CO. LTD NO. 71, TE LUN ROAD Jen Te Hsian, Tainan County, TW 717 |
| Contact | Phil Chen |
| 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 | 2006-05-10 |
| Decision Date | 2006-05-25 |
| Summary: | summary |