S8 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K112451
Device Name S8 DIAGNOSTIC 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 08/25/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No