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

    POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION

    K Number: K062091 · Decision Aug 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    9
    Review Days
    15

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    Basic Information

    Device Name
    POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
    K Number
    K062091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Porous Media Corp.
    Date Received
    July 24, 2006
    Decision Date
    August 8, 2006
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Porous Media Corp.

    K Number Device Name
    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
    K964979 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
    K952428 POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
    K934132 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER