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

    HUMIDIFIER ADAPTER

    K Number: K962079 · Decision Jul 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    21
    Review Days
    64

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    Basic Information

    Device Name
    HUMIDIFIER ADAPTER
    K Number
    K962079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    May 28, 1996
    Decision Date
    July 31, 1996
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    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 Automatic Liquid Packaging, Inc.

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    K973829 IRRIGATION BOTTLE
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    K901362 ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
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