FDA 510(k)

Huma RPM (RPM)

K 號：K230214 · 2023-06-02

決定日期2023-06-02

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

Huma RPM (RPM) is the device name listed in this FDA 510(k) record. The listed applicant is Medopad, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230214. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Huma RPM (RPM)?

Huma RPM (RPM) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Medopad, Inc.. The 510(k) number is K230214.

When did Huma RPM (RPM) receive FDA 510(k) clearance?

Huma RPM (RPM) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230214.

Who is the listed applicant for Huma RPM (RPM)?

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

What is the FDA product code for Huma RPM (RPM)?

The FDA product code for Huma RPM (RPM) is MWI.

相關器械（代碼：MWI）

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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