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

    GALILEO GOLD

    K Number: K040574 · Decision Oct 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    15
    Review Days
    237

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    Basic Information

    Device Name
    GALILEO GOLD
    K Number
    K040574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hamilton Medical, Inc.
    Date Received
    March 4, 2004
    Decision Date
    October 27, 2004
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Hamilton Medical, Inc.

    K Number Device Name
    K001686 GALILEO VENTILATOR
    K982910 HAMILTON MEDICAL GALILEOVENTILATOR
    K990293 ALADDIN II MONITORING OXYGEN/AIR MONITOR
    K960359 ALADDIN MONITORING OXYGEN/AIR MIXER
    K945740 INFANT FLOW SYSTEM
    K901448 VEOLAR VENTILATOR
    K900465 MAX TRANSPORT VENTILATOR
    K894426 LEONARDO INFORMATION SYSTEM
    K894316 AMADEUS VENTILATOR
    K881482 VEOLAR VENTILATOR
    Search all 15 clearances from Hamilton Medical, Inc. →