FDA 510(k)

可重用矽膠蓋 CPRmeter 2

K 號：K183348 · 2018-12-17

決定日期2018-12-17

產品代碼LIX

諮詢委員會履歷

決定相當於

器材摘要

Reusable Silicone Cover CPRmeter 2 is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical AS. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K183348. The device is classified under product code LIX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reusable Silicone Cover CPRmeter 2?

Reusable Silicone Cover CPRmeter 2 is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Laerdal Medical AS. The 510(k) number is K183348.

When did Reusable Silicone Cover CPRmeter 2 receive FDA 510(k) clearance?

Reusable Silicone Cover CPRmeter 2 received FDA 510(k) clearance on 2018-12-17, under 510(k) number K183348.

Who is the listed applicant for Reusable Silicone Cover CPRmeter 2?

The FDA 510(k) record lists Laerdal Medical AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable Silicone Cover CPRmeter 2?

The FDA product code for Reusable Silicone Cover CPRmeter 2 is LIX.

其他以 Laerdal Medical AS 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。

K251631BAG手動復甦器及其附件 K232111NeoBeat, NeoBeat Mini K173886CPRmeter 2 胸外壓急救反饋裝置

相關器械（代碼：LIX）

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。

K201581心肺復甦帶Credo K173886CPRmeter 2 胸外壓急救反饋裝置Laerdal Medical AS

官方來源

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