F10


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K110630
Device Name F10
Applicant
MEDIANA CO., LTD.
1650-1 donghwa-ri
munmak-cup
wonju-city, gangwon-do, 

KR

220-801

Applicant Contact amy m.h. kim
Regulation Number 884.2660
Classification Product Code
KNG  
Date Received 03/03/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No