FDA 510(k)

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

K-번호: K230483 · 2023-09-16

결정일2023-09-16

제품 코드CAH

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAH)

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