ECHO SOUNDER, ES-102EX


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K023143
Device Name ECHO SOUNDER, ES-102EX
Original Applicant
KOVEN TECHNOLOGY, INC.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Original Contact j. harvey knauss
Regulation Number 884.2660
Classification Product Code
KNG  
Date Received 09/20/2002
Decision Date 12/19/2002
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