ACHILLES


Device Classification Name

bone sonometer

510(k) Number K103633
Device Name ACHILLES
Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
no. 19 changjiang road
national hi-tech dev. zone
wuxi, jiangsu province, 

CN

214028

Applicant Contact chris paulik
Correspondent
GE MEDICAL SYSTEMS CHINA CO., LTD.
no. 19 changjiang road
national hi-tech dev. zone
wuxi, jiangsu province, 

CN

214028

Correspodent Contact chris paulik
Regulation Number 892.1180
Classification Product Code
MUA  
Date Received 12/13/2010
Decision Date 05/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No