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

    TRANSCEND HEATED HUMIDIFIER

    K Number: K131388 · Decision Sep 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    3
    Review Days
    135

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    Basic Information

    Device Name
    TRANSCEND HEATED HUMIDIFIER
    K Number
    K131388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Somnetics International, Inc.
    Date Received
    May 14, 2013
    Decision Date
    September 26, 2013
    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 Somnetics International, Inc.

    K Number Device Name
    K180388 Transcend 365 miniCPAP System
    K132127 TRANSCEND AUTO