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FDA 510(k) Application Details - K180419
Device Classification Name
Monitor, Ultrasonic, Fetal
More FDA Info for this Device
510(K) Number
K180419
Device Name
Monitor, Ultrasonic, Fetal
Applicant
Shenzhen IMDK Medical Technology Co., Ltd.
C Zone, 10F, Building16, Yuanshan Industrial B Area
Gongming Street, Guangming
Shenzhen 518106 CN
Other 510(k) Applications for this Company
Contact
Yuan Xia
Other 510(k) Applications for this Contact
Regulation Number
884.2660
More FDA Info for this Regulation Number
Classification Product Code
KNG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2018
Decision Date
07/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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