The following data is part of a premarket notification filed by Iei Technology Corp. with the FDA for Pacsmate Mmd-5201m Monitor.
| Device ID | K101796 |
| 510k Number | K101796 |
| Device Name: | PACSMATE MMD-5201M MONITOR |
| Classification | System, Image Processing, Radiological |
| Applicant | IEI TECHNOLOGY CORP. #6, LANE 29, WENMING ROAD Guishan, Taoyuan, TW 33383 |
| Contact | Hui-chen Kai |
| 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 | 2010-06-28 |
| Decision Date | 2010-07-15 |
| Summary: | summary |