FDA 510(k)

D R Burton 氧PAP

K 號：K192000 · 2020-02-19

決定日期2020-02-19

產品代碼BWF

諮詢委員會AN

決定相當於

器材摘要

D R Burton OxyPAP is the device name listed in this FDA 510(k) record. The listed applicant is D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2020-02-19 under 510(k) number K192000. 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 D R Burton OxyPAP?

D R Burton OxyPAP is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is D R Burton Healthcare, LLC. The 510(k) number is K192000.

When did D R Burton OxyPAP receive FDA 510(k) clearance?

D R Burton OxyPAP received FDA 510(k) clearance on 2020-02-19, under 510(k) number K192000.

Who is the listed applicant for D R Burton OxyPAP?

The FDA 510(k) record lists D R Burton Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D R Burton OxyPAP?

The FDA product code for D R Burton OxyPAP is BWF.

其他以 D R Burton Healthcare, LLC 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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