The following data is part of a premarket notification filed by Shenzhen Rf Tech Co., Ltd. with the FDA for 8ch Wrist Coil.
| Device ID | K223239 |
| 510k Number | K223239 |
| Device Name: | 8ch Wrist Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, CN 518132 |
| Contact | Gary Wang |
| Correspondent | Gary Wang Bonnier Quality Supervision Consulting (JM) Center Hailunxinyuan No.3203, Jianghai District Jiangmen, CN 529000 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-20 |
| Decision Date | 2022-12-08 |