• 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 K191802
Device Name Electric Breast Pump
Ningbo Huiyoo Baby Products Co. Ltd.
523# Cizhang Road, Zhangqi Industrial Area
Cixi,  CN 315313
Applicant Contact Xiaoping Liu
Mid-Link Consulting Co., Ltd
P.O Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.5160
Classification Product Code
Date Received07/03/2019
Decision Date 01/16/2020
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