CHISON, MODEL 8300


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K072210
Device Name CHISON, MODEL 8300
Applicant
CHISON MEDICAL IMAGING CO., LTD.
ste 8 zhongshan mansion, lane
999, zhongshan no.02 rd (s)
shanghai, 

CN

200030

Applicant Contact diana hong
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 08/09/2007
Decision Date 08/24/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No