FDA 510(k)

GEHC DXA骨密度仪，enCORE版本18

K号: K191112 · 2019-09-19

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

决定日期2019-09-19

产品代码KGI

咨询委员会RA

决定实质等同

器械摘要

GEHC DXA Bone Densitometers with enCORE version 18 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 2019-09-19 under 510(k) number K191112. 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 GEHC DXA Bone Densitometers with enCORE version 18?

GEHC DXA Bone Densitometers with enCORE version 18 is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K191112.

When did GEHC DXA Bone Densitometers with enCORE version 18 receive FDA 510(k) clearance?

GEHC DXA Bone Densitometers with enCORE version 18 received FDA 510(k) clearance on 2019-09-19, under 510(k) number K191112.

Who is the listed applicant for GEHC DXA Bone Densitometers with enCORE version 18?

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 GEHC DXA Bone Densitometers with enCORE version 18?

The FDA product code for GEHC DXA Bone Densitometers with enCORE version 18 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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