Device Classification Name |
Monitor, Ultrasonic, Fetal
|
510(k) Number |
K182526 |
Device Name |
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) |
Applicant |
Vcomin Technology Limited |
2&3 FI., No. 1, Kangzheng Rd., Buji Town |
Shenzhen,
CN
518110
|
|
Applicant Contact |
Han JieLin |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
1122#, International Mayor Communication Center |
55 Shizhou Zhong Road, Nanshan District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Lucy Yan |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 09/11/2018 |
Decision Date | 05/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|