FDA 510(k)

Hudson RCI Voldyne體積訓練器

K 號：K182847 · 2019-07-01

決定日期2019-07-01

產品代碼BWF

諮詢委員會AN

決定相當於

器材摘要

Hudson RCI Voldyne Volumetric Exerciser is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K182847. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hudson RCI Voldyne Volumetric Exerciser?

Hudson RCI Voldyne Volumetric Exerciser is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K182847.

When did Hudson RCI Voldyne Volumetric Exerciser receive FDA 510(k) clearance?

Hudson RCI Voldyne Volumetric Exerciser received FDA 510(k) clearance on 2019-07-01, under 510(k) number K182847.

Who is the listed applicant for Hudson RCI Voldyne Volumetric Exerciser?

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

What is the FDA product code for Hudson RCI Voldyne Volumetric Exerciser?

The FDA product code for Hudson RCI Voldyne Volumetric Exerciser is BWF.

其他以 Teleflexmedical, Inc. 為申請人之記錄

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相關器械（代碼：BWF）

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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