FDA 510(k)

F6S 全面罩 (F6S)；P6S 鼻枕接口 (P6S)

K 號：K253166 · 2026-04-29

決定日期2026-04-29

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is the device name listed in this FDA 510(k) record. The listed applicant is BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K253166. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K253166.

When did F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) receive FDA 510(k) clearance?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) received FDA 510(k) clearance on 2026-04-29, under 510(k) number K253166.

Who is the listed applicant for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

FDA 510(k) 記錄將 BMC Medical Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

The FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is BZD.

其他以 BMC Medical Co., Ltd. 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。

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相關器械（代碼：BZD）

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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