FDA 510(k)

Aria

K号: K180782 · 2018-04-20

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

决定日期2018-04-20

产品代码KGI

咨询委员会RA

决定实质等同

器械摘要

Aria 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 2018-04-20 under 510(k) number K180782. 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 Aria?

Aria is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K180782.

When did Aria receive FDA 510(k) clearance?

Aria received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180782.

Who is the listed applicant for Aria?

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 Aria?

The FDA product code for Aria 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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