S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K110510
Device Name S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Applicant
SONOSCAPE COMPANY LIMITED
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
SONOSCAPE COMPANY LIMITED
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 02/22/2011
Decision Date 05/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No