CUBESCAN / BIOCON-700


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K111021
Device Name CUBESCAN / BIOCON-700
Applicant
MCUBE TECHNOLOGY CO., LTD.
803 shinnae-technotown
485 sangbong-dong
chungnang-ku, seoul, 

KR

131-220

Applicant Contact seungtai kim
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
IYO  
Date Received 04/12/2011
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No