FDA 510(k)

AF531 鼻咽腔SE面罩

K 號：K243394 · 2024-12-30

決定日期2024-12-30

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

AF531 Oro-Nasal SE Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2024-12-30 under 510(k) number K243394. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AF531 Oro-Nasal SE Face Mask?

AF531 Oro-Nasal SE Face Mask is a medical device that received FDA 510(k) clearance on 2024-12-30. The listed applicant is Respironics, Inc.. The 510(k) number is K243394.

When did AF531 Oro-Nasal SE Face Mask receive FDA 510(k) clearance?

AF531 Oro-Nasal SE Face Mask received FDA 510(k) clearance on 2024-12-30, under 510(k) number K243394.

Who is the listed applicant for AF531 Oro-Nasal SE Face Mask?

FDA 510(k) 記錄將Respironics, Inc.列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AF531 Oro-Nasal SE Face Mask?

The FDA product code for AF531 Oro-Nasal SE Face Mask is CBK.

其他以 Respironics, Inc. 為申請人之記錄

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相關器械（代碼：CBK）

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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