Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182710
Device Classification Name
Monitor, Ultrasonic, Fetal
More FDA Info for this Device
510(K) Number
K182710
Device Name
Monitor, Ultrasonic, Fetal
Applicant
ShenzZhen Luckcome Technology Inc., Ltd.
Floor 6A, 6th Building , Tongfuyu Industrial Park,
Nanshan District
Shenzhen 518055 CN
Other 510(k) Applications for this Company
Contact
Can He
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
09/27/2018
Decision Date
03/01/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact