FDA 510(k)

病人監護線材（SpO2 延長線材）

K 號：K192404 · 2020-06-22

決定日期2020-06-22

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

Patient Monitoring Cable (SpO2 Extension Cable) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192404. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K192404.

When did Patient Monitoring Cable (SpO2 Extension Cable) receive FDA 510(k) clearance?

Patient Monitoring Cable (SpO2 Extension Cable) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192404.

Who is the listed applicant for Patient Monitoring Cable (SpO2 Extension Cable)?

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

What is the FDA product code for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA product code for Patient Monitoring Cable (SpO2 Extension Cable) is DSA.

其他以 Shenzhen Coreray Technology, 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。

K173368可重用及一次性SpO2感測器 K172797心電圖電纜/導電線

相關器械（代碼：DSA）

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

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