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FDA 510(k)

Acapella Choice Blue 振動式PEP設備

K 號:K181660 · 2019-10-24

決定日期2019-10-24
產品代碼BWF
諮詢委員會AN
決定相當於

器材摘要

Acapella Choice Blue Vibratory PEP Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K181660. 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 Acapella Choice Blue Vibratory PEP Device?

Acapella Choice Blue Vibratory PEP Device is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Smiths Medical. The 510(k) number is K181660.

When did Acapella Choice Blue Vibratory PEP Device receive FDA 510(k) clearance?

Acapella Choice Blue Vibratory PEP Device received FDA 510(k) clearance on 2019-10-24, under 510(k) number K181660.

Who is the listed applicant for Acapella Choice Blue Vibratory PEP Device?

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

What is the FDA product code for Acapella Choice Blue Vibratory PEP Device?

The FDA product code for Acapella Choice Blue Vibratory PEP Device is BWF.

相關臨床試驗

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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。

官方來源

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