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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact