FDA 510(k)

Avail

K 號：K172079 · 2017-10-19

決定日期2017-10-19

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Avail is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K172079. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avail?

Avail is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K172079.

When did Avail receive FDA 510(k) clearance?

Avail received FDA 510(k) clearance on 2017-10-19, under 510(k) number K172079.

Who is the listed applicant for Avail?

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

What is the FDA product code for Avail?

The FDA product code for Avail is NUH.

其他以 Omron Healthcare, Inc. 為申請人之記錄

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