BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K230483 · Decision Sep 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    5
    Review Days
    205

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    Basic Information

    Device Name
    Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
    K Number
    K230483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Passy-Muir, Inc.
    Date Received
    February 23, 2023
    Decision Date
    September 16, 2023
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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    Other Clearances by Passy-Muir, Inc.

    K Number Device Name
    K990905 PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
    K970365 PASSY-MUIR O2 ADAPTER; PMA2000
    K962714 PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
    K944451 PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)