FDA 510(k)

氧2Pro

K 號：K222511 · 2023-11-21

決定日期2023-11-21

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

Oxy2Pro is the device name listed in this FDA 510(k) record. The listed applicant is Southmedic, Inc.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K222511. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oxy2Pro?

Oxy2Pro is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Southmedic, Inc.. The 510(k) number is K222511.

When did Oxy2Pro receive FDA 510(k) clearance?

Oxy2Pro received FDA 510(k) clearance on 2023-11-21, under 510(k) number K222511.

Who is the listed applicant for Oxy2Pro?

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

What is the FDA product code for Oxy2Pro?

The FDA product code for Oxy2Pro is CCK.

相關器械（代碼：CCK）

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官方來源

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