BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    MEDISIZE GOLD HEATER AND BOOSTER

    K Number: K070714 · Decision Apr 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    4
    Review Days
    47

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    Basic Information

    Device Name
    MEDISIZE GOLD HEATER AND BOOSTER
    K Number
    K070714
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medisize BV
    Date Received
    March 14, 2007
    Decision Date
    April 30, 2007
    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 Medisize BV

    K Number Device Name
    K122885 MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
    K081536 MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
    K052615 MEDISIZE GOLD