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, blood-flow, ultrasonic
510(k) Number K101960
Device Name SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
Applicant
EDAN INSTRUMENTS, INC.
3/F-B, NANSHAN MEDICAL
EQUIPMENT PARK, NANHAI RD 1019
SHENZHEN,  CN 518067
Applicant Contact YUE QIUHONG
Correspondent
EDAN INSTRUMENTS, INC.
3/F-B, NANSHAN MEDICAL
EQUIPMENT PARK, NANHAI RD 1019
SHENZHEN,  CN 518067
Correspondent Contact YUE QIUHONG
Regulation Number884.2660
Classification Product Code
HEP  
Subsequent Product Code
KNG  
Date Received07/12/2010
Decision Date 08/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-