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 K140579
Device Name ULTRASONIC POCKET DOPPLER
Applicant
EDAN INSTRUMENTS, INC.
NANHAI RD 1019 NO. SHEKOU, NANSHAN
SHENZHEN, GUANGDONG,  CN 518067
Applicant Contact QUEENA CHEN
Correspondent
EDAN INSTRUMENTS, INC.
NANHAI RD 1019 NO. SHEKOU, NANSHAN
SHENZHEN, GUANGDONG,  CN 518067
Correspondent Contact QUEENA CHEN
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
DPW  
Date Received03/06/2014
Decision Date 02/06/2015
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
-
-