FDA 510(k)

GE Lunar DXA骨密度仪，enCORE版本17

K号: K161682 · 2016-12-02

申请人GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

决定日期2016-12-02

产品代码KGI

咨询委员会RA

决定实质等同

器械摘要

GE Lunar DXA Bone Densitometers with enCORE version 17 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K161682. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GE Lunar DXA Bone Densitometers with enCORE version 17?

GE Lunar DXA Bone Densitometers with enCORE version 17 is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161682.

When did GE Lunar DXA Bone Densitometers with enCORE version 17 receive FDA 510(k) clearance?

GE Lunar DXA Bone Densitometers with enCORE version 17 received FDA 510(k) clearance on 2016-12-02, under 510(k) number K161682.

Who is the listed applicant for GE Lunar DXA Bone Densitometers with enCORE version 17?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE Lunar DXA Bone Densitometers with enCORE version 17?

The FDA product code for GE Lunar DXA Bone Densitometers with enCORE version 17 is KGI.

列明GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC为申报人的其他记录

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