The following data is part of a premarket notification filed by Neuf Inc. with the FDA for Nflk-2501 Portable X-ray Unit.
| Device ID | K211383 |
| 510k Number | K211383 |
| Device Name: | NFLK-2501 Portable X-ray Unit |
| Classification | System, X-ray, Mobile |
| Applicant | NEUF Inc. #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si Jeollanam-do, KR 58034 |
| Contact | Woo Sang Lee |
| Correspondent | Woo Sung Park MEDMONTS Co., Ltd. ife Officetel 320, 40, 63-ro, Youngdeungpo-gu Soul, KR 07345 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-08-13 |