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 Monitor, Ultrasonic, Fetal
510(k) Number K252669
Device Name Fetal Doppler U8-25, U9-25
Applicant
Zhongshan Xiaolan Town Senlan Electronic Factory
2/F, Plant 3, #39 Of Jucheng Ave. E.
Xinshi Community, Xiaolan Town
Zhongshan,  CN 528400
Applicant Contact Runtong Zhong
Correspondent
Shenzhen Aisnwei Medical Technology Service Co., Ltd.
Rm. B07, 3rd Floor, #690, Dongmen Bldg.
Xinniu Community, Minzhi St., Longhua District
Shenzhen,  CN 518131
Correspondent Contact Ailing Fu
Regulation Number884.2660
Classification Product Code
KNG  
Date Received08/25/2025
Decision Date 01/08/2026
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
-
-