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FDA 510(k)

Aurora

K 號：K181636 · 2018-07-20

申請人Sodium Systems, LLC
決定日期2018-07-20
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Sodium Systems, LLC. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181636. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aurora?

Aurora is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Sodium Systems, LLC. The 510(k) number is K181636.

When did Aurora receive FDA 510(k) clearance?

Aurora received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181636.

Who is the listed applicant for Aurora?

The FDA 510(k) record lists Sodium Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora?

The FDA product code for Aurora is MUH.

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