The following data is part of a premarket notification filed by Infinitt Co., Ltd. with the FDA for Infinitt Xelis.
| Device ID | K082990 |
| 510k Number | K082990 |
| Device Name: | INFINITT XELIS |
| Classification | System, Image Processing, Radiological |
| Applicant | INFINITT CO., LTD. 12F DAERUNG POST TOWER III 182-4 GURO-DONG, GURO-GU Seoul, KR 152-050 |
| Contact | Tristan Choi |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-07 |
| Decision Date | 2008-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809278790079 | K082990 | 000 |