FDA 510(k)

Hudson RCI Triflo II 勸誘深呼吸運動器

K 號：K220565 · 2022-10-25

決定日期2022-10-25

產品代碼BWF

諮詢委員會AN

決定相當於

器材摘要

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K220565. 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 Triflo II Incentive Deep Breathing Exerciser?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Medline Industries, Inc.. The 510(k) number is K220565.

When did Hudson RCI Triflo II Incentive Deep Breathing Exerciser receive FDA 510(k) clearance?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser received FDA 510(k) clearance on 2022-10-25, under 510(k) number K220565.

Who is the listed applicant for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

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

What is the FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

The FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser is BWF.

其他以 Medline Industries, Inc. 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。

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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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