FDA 510(k)

心肺復甦帶

K 號：K201581 · 2021-03-06

申請人Credo

決定日期2021-03-06

產品代碼LIX

諮詢委員會履歷

決定相當於

器材摘要

CPR BAND is the device name listed in this FDA 510(k) record. The listed applicant is Credo. It received FDA 510(k) clearance on 2021-03-06 under 510(k) number K201581. 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 CPR BAND?

CPR BAND is a medical device that received FDA 510(k) clearance on 2021-03-06. The listed applicant is Credo. The 510(k) number is K201581.

When did CPR BAND receive FDA 510(k) clearance?

CPR BAND received FDA 510(k) clearance on 2021-03-06, under 510(k) number K201581.

Who is the listed applicant for CPR BAND?

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

What is the FDA product code for CPR BAND?

The FDA product code for CPR BAND is LIX.

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。

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官方來源

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