FDA 510(k)

心電血氧濃度計

K 號：K212300 · 2022-02-25

申請人Shenzhen Mericonn Technology Co., Ltd.

決定日期2022-02-25

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K212300. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulse Oximeter?

Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. The 510(k) number is K212300.

When did Pulse Oximeter receive FDA 510(k) clearance?

Pulse Oximeter received FDA 510(k) clearance on 2022-02-25, under 510(k) number K212300.

Who is the listed applicant for Pulse Oximeter?

FDA 510(k) 記錄將深圳美康科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Pulse Oximeter?

The FDA product code for Pulse Oximeter is DQA.

其他以 Shenzhen Mericonn Technology 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。

K254171網狀噴霧器（UN204）；網狀噴霧器（UN205）；網狀噴霧器（UN209）；網狀噴霧器（UN210）K212084胎兒多普勒

相關器械（代碼：DQA）

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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