FDA 510(k)

Sapphire NC 24

K 號：K211807 · 2021-10-14

申請人OrbusNeich Medical (Shenzhen) Co., Ltd.

決定日期2021-10-14

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Sapphire NC 24 is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211807. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sapphire NC 24?

Sapphire NC 24 is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K211807.

When did Sapphire NC 24 receive FDA 510(k) clearance?

Sapphire NC 24 received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211807.

Who is the listed applicant for Sapphire NC 24?

FDA 510(k) 記錄將OrbusNeich Medical (Shenzhen) Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Sapphire NC 24?

The FDA product code for Sapphire NC 24 is LOX.

其他以 OrbusNeich Medical (Shenzhen) Co., Ltd. 為申請人之記錄

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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相關器械（代碼：LOX）

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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