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 K182190
Device Name Fetal Doppler
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Room 202, HaoGu Industry Park, 2037 Guanguang Road,
Guangming district
Shenzhen,  CN 518105
Applicant Contact Qihuan Zhao
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Room 202, HaoGu Industry Park, 2037 Guanguang Road,
Guangming district
Shenzhen,  CN 518105
Correspondent Contact Qihuan Zhao
Regulation Number884.2660
Classification Product Code
KNG  
Date Received08/13/2018
Decision Date 12/19/2018
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
-
-