FDA 510(k)

Aer X

K 號：K200496 · 2020-07-24

決定日期2020-07-24

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Aer X is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K200496. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aer X?

Aer X is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is 3B Medical, Inc.. The 510(k) number is K200496.

When did Aer X receive FDA 510(k) clearance?

Aer X received FDA 510(k) clearance on 2020-07-24, under 510(k) number K200496.

Who is the listed applicant for Aer X?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aer X?

The FDA product code for Aer X is CAW.

其他以 3B Medical, Inc. 為申請人之記錄

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官方來源

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