The following data is part of a premarket notification filed by Shenzhen Rftech Co., Ltd. with the FDA for 8ch Foot Ankle Coil.
| Device ID | K151653 |
| 510k Number | K151653 |
| Device Name: | 8ch Foot Ankle Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SHENZHEN RFTECH CO., LTD. 2-F, BLDG 4, JUHUI INDUSTRIAL PARK, TIANLIAO, GUANGMING, Shenzhen, CN 51832 |
| Contact | Ke Xi |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD 7TH FLOOR, JINGUI BUSINESS BUILDING, NO. 982 CONGYUN RD., BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938146600010 | K151653 | 000 |