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: K103633
• 510k Number: K103633
• 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: Chris Paulik
• Correspondent: Chris Paulik; 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: 2010-12-13
• Decision Date: 2011-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682116978	K103633	000