The following data is part of a premarket notification filed by Shenzhen Rf Tech Co., Ltd. with the FDA for 8ch Flex Suite.
| Device ID | K172222 |
| 510k Number | K172222 |
| Device Name: | 8ch Flex Suite |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, CN 518132 |
| Contact | Ke Xi |
| Correspondent | Ke Xi Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, CN 518132 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2017-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16938146600055 | K172222 | 000 |
| 16938146600048 | K172222 | 000 |
| 16938146600031 | K172222 | 000 |