FDA 510(k)

貝美斯細菌過濾器和HMEF

K 號：K241339 · 2024-11-14

決定日期2024-11-14

產品代碼CAH

諮詢委員會AN

決定相當於

器材摘要

Besmed Bacterial Filter and HMEF is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K241339. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Besmed Bacterial Filter and HMEF?

Besmed Bacterial Filter and HMEF is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Besmed Health Business Corp. The 510(k) number is K241339.

When did Besmed Bacterial Filter and HMEF receive FDA 510(k) clearance?

Besmed Bacterial Filter and HMEF received FDA 510(k) clearance on 2024-11-14, under 510(k) number K241339.

Who is the listed applicant for Besmed Bacterial Filter and HMEF?

The FDA 510(k) record lists Besmed Health Business Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Besmed Bacterial Filter and HMEF?

The FDA product code for Besmed Bacterial Filter and HMEF is CAH.

其他以 Besmed Health Business Corp 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。

K172804貝美斯峰流速計 K160112貝斯美 PEEP 過換氣閥

相關器械（代碼：CAH）

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。

K252643Iso-Gard過濾直管；濕氣通風過濾器小型斜角Teleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® 呼氣過濾器Ambu A/S K222917呼吸回路細菌/病毒過濾器Shaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir 氣管切開術病毒及細菌呼吸道保護過濾器 (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 角度呼吸過濾器（1545020）Intersurgical , Ltd.K221472過濾器及HME/過濾器Ningbo Huakun Medical Equipment Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。