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 K080087
Device Name SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
Applicant
Edan Instruments, Inc.
1 Odell Plaza
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Edan Instruments, Inc.
1 Odell Plaza
Yonkers,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
HEP  
Date Received01/11/2008
Decision Date 03/11/2008
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
Predetermined Change
Control Plan Authorized		 No
-
-