FDA 510(k)

結合Aerobika OPEP與VersaPAP設備

K 號：K183108 · 2019-08-16

決定日期2019-08-16

產品代碼BWF

諮詢委員會AN

決定相當於

器材摘要

Combined Aerobika OPEP and VersaPAP device is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K183108. 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 Combined Aerobika OPEP and VersaPAP device?

Combined Aerobika OPEP and VersaPAP device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Trudell Medical International. The 510(k) number is K183108.

When did Combined Aerobika OPEP and VersaPAP device receive FDA 510(k) clearance?

Combined Aerobika OPEP and VersaPAP device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K183108.

Who is the listed applicant for Combined Aerobika OPEP and VersaPAP device?

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

What is the FDA product code for Combined Aerobika OPEP and VersaPAP device?

The FDA product code for Combined Aerobika OPEP and VersaPAP device is BWF.

其他以 Trudell Medical International 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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