Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pump, Breast, Powered
510(k) Number K230102
Device Name Smart double sides wearable breast pump, Electric bilateral breast pump
Applicant
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Block A 16 Huifengxi 3rd,Pingnan Industry Zone, Zhongkai
H-I-Tech District
Huizhou,  CN 516000
Applicant Contact Dongan Zhang
Correspondent
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Block A 16 Huifengxi 3rd,Pingnan Industry Zone, Zhongkai
H-I-Tech District
Huizhou,  CN 516000
Correspondent Contact Rain Yip
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/13/2023
Decision Date 09/21/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-