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

    TAGA VELOCITY HUMIDIFIER

    K Number: K031179 · Decision Jul 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    3
    Review Days
    93

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    Basic Information

    Device Name
    TAGA VELOCITY HUMIDIFIER
    K Number
    K031179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taga Medical Technologies, Inc.
    Date Received
    April 15, 2003
    Decision Date
    July 17, 2003
    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 Taga Medical Technologies, Inc.

    K Number Device Name
    K040507 TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
    K010578 TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017