Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K223225 |
Device Name |
8ch T/R Knee Coil |
Applicant |
Shenzhen RF Tech Co., Ltd. |
2-F,BLD4 Juhui Industrial Park, Tianliao,Guangming |
Shenzhen,
CN
518132
|
|
Applicant Contact |
Gary Wang |
Correspondent |
Bonnier Quality Supervision Consulting (JM) Center |
Hailunxinyuan No.3203, Jianghai District |
Jiangmen,
CN
529000
|
|
Correspondent Contact |
Gary Wang |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 10/18/2022 |
Decision Date | 02/14/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|