ACHILLES

Bone Sonometer

GE MEDICAL SYSTEMS CHINA CO., LTD.

The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Achilles.

Pre-market Notification Details

• Device ID: K123238
• 510k Number: K123238
• Device Name: ACHILLES
• Classification: Bone Sonometer
• Applicant: GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE Wuxi, Jiangsu Province, CN 214028
• Contact: Liu Zhao
• Correspondent: Liu Zhao; GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE Wuxi, Jiangsu Province, CN 214028
• Product Code: MUA
• CFR Regulation Number: 892.1180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-10-16
• Decision Date: 2013-02-25
• Summary: summary