FDA 510(k)

Auxo A300, A150 及 APod

K 號：K220543 · 2022-04-20

決定日期2022-04-20

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Auxo A300, A150 and APod is the device name listed in this FDA 510(k) record. The listed applicant is Auxo Hair, LLC. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K220543. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Auxo A300, A150 and APod?

Auxo A300, A150 and APod is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Auxo Hair, LLC. The 510(k) number is K220543.

When did Auxo A300, A150 and APod receive FDA 510(k) clearance?

Auxo A300, A150 and APod received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220543.

Who is the listed applicant for Auxo A300, A150 and APod?

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

What is the FDA product code for Auxo A300, A150 and APod?

The FDA product code for Auxo A300, A150 and APod is OAP.

相關器械（代碼：OAP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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