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FDA 510(k) Application Details - K232774
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K232774
Device Name
Pump, Breast, Powered
Applicant
Ningbo Dearevery Electronic Technology Co., LTD
No3-1, Gongji South Road, Hudi Village, Linshan Town
Yuyao 315460 CN
Other 510(k) Applications for this Company
Contact
Kelong Zhang
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2023
Decision Date
06/06/2024
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
FDA Source Information for K232774
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