DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110841
Device Name DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
Applicant
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
77 jinsha road
shantou, guangdong, 

CN

515041

Applicant Contact flower cai
Correspondent
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
77 jinsha road
shantou, guangdong, 

CN

515041

Correspodent Contact flower cai
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 03/25/2011
Decision Date 04/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No