FM20


Device Classification Name

system, monitoring, perinatal

510(k) Number K110612
Device Name FM20
Applicant
MEDIANA CO., LTD.
wonju medical ind. park
1650-1 donghwa-ri, munmak-eup
wonju-si, gangwon-do, 

KR

220-801

Applicant Contact amy kim
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 03/03/2011
Decision Date 11/08/2011
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