Device Classification Name |
monitor, ultrasonic, fetal
|
510(k) Number |
K180419 |
Device Name |
Ultrasonic Doppler (Model YM-2T8) |
Applicant |
Shenzhen IMDK Medical Technology Co., Ltd. |
C Zone, 10F, Building16, Yuanshan Industrial B Area |
Gongming Street, Guangming |
Shenzhen,
CN
518106
|
|
Applicant Contact |
Yuan Xia |
Correspondent |
Shenzhen IMDK Medical Technology Co., Ltd. |
C Zone, 10F, Building16, Yuanshan Industrial B Area |
Gongming Street, Guangming |
Shenzhen,
CN
518106
|
|
Correspondent Contact |
Yuan Xia |
Regulation Number | 884.2660
|
Classification Product Code |
|
Date Received | 02/15/2018 |
Decision Date | 07/19/2018 |
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
|
|
|