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 K082480
Device Name CONTEC POCKET FETAL DOPPLER
Applicant
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI,  CN 20030
Applicant Contact Diana Hong
Correspondent
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI,  CN 20030
Correspondent Contact Diana Hong
Regulation Number884.2660
Classification Product Code
KNG  
Date Received08/28/2008
Decision Date 02/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-