FDA 510(k)

Aria

K 號：K180782 · 2018-04-20

申請人GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

決定日期2018-04-20

產品代碼KGI

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.