FDA 510(k)

RVS-100 頻脈監測器

K 號：K170538 · 2017-10-17

決定日期2017-10-17

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

RVS-100 Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K170538. 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 RVS-100 Vital Signs Monitor?

RVS-100 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Rudolf Riester GmbH. The 510(k) number is K170538.

When did RVS-100 Vital Signs Monitor receive FDA 510(k) clearance?

RVS-100 Vital Signs Monitor received FDA 510(k) clearance on 2017-10-17, under 510(k) number K170538.

Who is the listed applicant for RVS-100 Vital Signs Monitor?

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

What is the FDA product code for RVS-100 Vital Signs Monitor?

The FDA product code for RVS-100 Vital Signs Monitor is MWI.

其他以 Rudolf Riester GmbH 為申請人之記錄

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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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