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

    POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER

    K Number: K964979 · Decision Mar 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
    K Number
    K964979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Porous Media Corp.
    Date Received
    December 12, 1996
    Decision Date
    March 11, 1997
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    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 Porous Media Corp.

    K Number Device Name
    K062091 POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
    K061426 OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
    K990276 POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
    K982385 POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
    K982127 POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
    K965020 POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
    K952428 POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
    K934132 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER