FDA 510(k)

可重用SpO2感測器，一次性SpO2感測器

K 號：K172981 · 2018-06-08

決定日期2018-06-08

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Reusable SpO2 Sensors, Disposable SpO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K172981. 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 Reusable SpO2 Sensors, Disposable SpO2 Sensors?

Reusable SpO2 Sensors, Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K172981.

When did Reusable SpO2 Sensors, Disposable SpO2 Sensors receive FDA 510(k) clearance?

Reusable SpO2 Sensors, Disposable SpO2 Sensors received FDA 510(k) clearance on 2018-06-08, under 510(k) number K172981.

Who is the listed applicant for Reusable SpO2 Sensors, Disposable SpO2 Sensors?

The FDA 510(k) record lists APK Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable SpO2 Sensors, Disposable SpO2 Sensors?

The FDA product code for Reusable SpO2 Sensors, Disposable SpO2 Sensors is DQA.

其他以 APK Technology Co., Ltd. 為申請人之記錄

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K250425紫外光療法設備 K170536心電圖一次性導線

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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