可重用血氧濃度感測器
K 號：K191420 · 2019-10-11
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器材摘要
Reusable SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191420. 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 Sensor?
Reusable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K191420.
When did Reusable SpO2 Sensor receive FDA 510(k) clearance?
Reusable SpO2 Sensor received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191420.
Who is the listed applicant for Reusable SpO2 Sensor?
The FDA 510(k) record lists Shenzhen Changke Connect Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reusable SpO2 Sensor?
The FDA product code for Reusable SpO2 Sensor is DQA.
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其他以 Shenzhen Changke Connect Electronics Co., Ltd. 為申請人之記錄
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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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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