Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K201965 |
Device Name |
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System |
Applicant |
Chison Medical Technologies Co., Ltd. |
No.228, Changjiang East Road, Block 51 and 53, Phase 5, |
Shuofang Industrial Park |
Wuxi,
CN
214142
|
|
Applicant Contact |
Qifei Liu |
Correspondent |
Chison Medical Technologies Co., Ltd. |
No.228, Changjiang East Road, Block 51 and 53, Phase 5, |
Shuofang Industrial Park, Xinwu District |
Wuxi,
CN
214142
|
|
Correspondent Contact |
Qifei Liu |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/15/2020 |
Decision Date | 03/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|