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FDA 510(k)

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

K-Number: K230483 · 2023-09-16

ApplicantPassy-Muir, Inc.
Decision Date2023-09-16
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a medical device manufactured by Passy-Muir, Inc.. It received FDA 510(k) clearance on 2023-09-16 under approval number K230483. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Passy-Muir, Inc.. The 510(k) number is K230483.

When was Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) approved by the FDA?

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

What company makes Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)?

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is manufactured by Passy-Muir, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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