FDA 510(k)

CARESCAPE 呼吸模組，E-sCO，E-sCOV，E-sCOVX，E-sCAiO，E-sCAiOV，E-sCAiOVX 及相關配件

K 號：K171028 · 2017-08-17

決定日期2017-08-17

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171028. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories?

CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K171028.

When did CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories receive FDA 510(k) clearance?

CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171028.

Who is the listed applicant for CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories?

FDA 510(k) 記錄將 GE Healthcare Finland Oy 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories?

The FDA product code for CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories is CCK.

其他以 GE Healthcare Finland Oy 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。

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M K260343Carescape Canvas 1000；Carescape Canvas 智能顯示器 K223531CARESCAPE Canvas 1000、CARESCAPE Canvas Smart Display、CARESCAPE Canvas D19、F2 框架（F2-01）K213336Carescape B850, E-musb K213181CARESCAPE B650, E-musb K213363CARESCAPE B450, E-musb

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相關器械（代碼：CCK）

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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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。