FEEL-DRCS


Device Classification Name

system, image processing, radiological

510(k) Number K110033
Device Name FEEL-DRCS
Applicant
IMFOU CO., LTD
#821 samil plaza, 837-26
yeuksam-dong
gangnam-gu, seoul, 

KR

135-768

Applicant Contact ho dong yang
Correspondent
IMFOU CO., LTD
#821 samil plaza, 837-26
yeuksam-dong
gangnam-gu, seoul, 

KR

135-768

Correspodent Contact ho dong yang
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/05/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No