• 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 K031504
Device Name ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
Applicant
KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number884.2660
Classification Product Code
KNG  
Date Received05/14/2003
Decision Date 07/18/2003
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
-
-