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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number892.1180
Classification Product Code
MUA  
Subsequent Product Code
LLZ  
Date Received10/16/2012
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
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