免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Medke 輸氧量手指感測器

K 號:K152390 · 2016-08-18

決定日期2016-08-18
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Medke Oximetry Finger Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K152390. 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 Medke Oximetry Finger Sensor?

Medke Oximetry Finger Sensor is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K152390.

When did Medke Oximetry Finger Sensor receive FDA 510(k) clearance?

Medke Oximetry Finger Sensor received FDA 510(k) clearance on 2016-08-18, under 510(k) number K152390.

Who is the listed applicant for Medke Oximetry Finger Sensor?

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

What is the FDA product code for Medke Oximetry Finger Sensor?

The FDA product code for Medke Oximetry Finger Sensor is DQA.

相關臨床試驗

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。

其他以 Shenzhen Medke 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。

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。

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。

↑