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 | K200836 |
| 510k Number | K200836 |
| 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 | Gary Wang |
| Correspondent | Gary Wang 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 | 2020-03-31 |
| Decision Date | 2020-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16938146600086 | K200836 | 000 |
| 16938146600079 | K200836 | 000 |
| 06938146600065 | K200836 | 000 |