M5 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K080640
Device Name M5 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 03/06/2008
Decision Date 03/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No