FDA 510(k)

ReDe 面罩

K 號：K161953 · 2017-02-17

決定日期2017-02-17

產品代碼PRK

諮詢委員會AN

決定相當於

器材摘要

ReDe Mask is the device name listed in this FDA 510(k) record. The listed applicant is Tereopneuma. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K161953. The device is classified under product code PRK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ReDe Mask?

ReDe Mask is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Tereopneuma. The 510(k) number is K161953.

When did ReDe Mask receive FDA 510(k) clearance?

ReDe Mask received FDA 510(k) clearance on 2017-02-17, under 510(k) number K161953.

Who is the listed applicant for ReDe Mask?

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

What is the FDA product code for ReDe Mask?

The FDA product code for ReDe Mask is PRK.

官方來源

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