Device Classification Name |
bone sonometer
|
510(k) Number |
K123238 |
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 |
liu zhao |
Correspondent |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
NO. 19 CHANGJIANG ROAD |
NATIONAL HI-TECH DEV. ZONE |
wuxi, jiangsu province,
CN
214028
|
|
Correspondent Contact |
liu zhao |
Regulation Number | 892.1180
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/16/2012 |
Decision Date | 02/25/2013 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|