Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K211940 |
Device Name |
Fetal Doppler |
Applicant |
Shenzhen Taikang Medical Equipment Co., Ltd. |
3F East, Building 4, Lanzhu East Road 8, Grand Industrial |
Park, Pingshan District |
Shenzhen,
CN
518015
|
|
Applicant Contact |
Shigui Du |
Correspondent |
Shenzhen Taikang Medical Equipment Co., Ltd. |
3F East, Building 4, Lanzhu East Road 8, Grand Industrial |
Park, Pingshan District |
Shenzhen,
CN
518015
|
|
Correspondent Contact |
Shigui Du |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 06/23/2021 |
Decision Date | 01/07/2022 |
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
|
|
|