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FDA 510(k)

Passy Muir 氣管切開術病毒及細菌呼吸道保護過濾器 (PM-APF15)

K 號：K230483 · 2023-09-16

申請人Passy-Muir, Inc.
決定日期2023-09-16
產品代碼CAH
諮詢委員會AN
決定相當於

器材摘要

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is the device name listed in this FDA 510(k) record. The listed applicant is Passy-Muir, Inc.. It received FDA 510(k) clearance on 2023-09-16 under 510(k) number K230483. 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 Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)?

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a medical device that received FDA 510(k) clearance on 2023-09-16. The listed applicant is Passy-Muir, Inc.. The 510(k) number is K230483.

When did Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) receive FDA 510(k) clearance?

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) received FDA 510(k) clearance on 2023-09-16, under 510(k) number K230483.

Who is the listed applicant for Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)?

The FDA 510(k) record lists Passy-Muir, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)?

The FDA product code for Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is CAH.

相關臨床試驗

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：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。

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