The following data is part of a premarket notification filed by Iei Technology Corp. with the FDA for Pacsmate Mmd-3213m Monitor.
| Device ID | K082496 |
| 510k Number | K082496 |
| Device Name: | PACSMATE MMD-3213M MONITOR |
| Classification | System, Image Processing, Radiological |
| Applicant | IEI TECHNOLOGY CORP. NO. 29 JHONG-SING ROAD SI-JHIH CITY Taipei Country, TW 221 |
| Contact | Shally Chen |
| Correspondent | Morton Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-29 |
| Decision Date | 2008-09-09 |
| Summary: | summary |