DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K111435
Device Name DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 05/23/2011
Decision Date 07/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No