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

    VEOLAR VENTILATOR

    K Number: K881482 · Decision Jun 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    15
    Review Days
    69

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    Basic Information

    Device Name
    VEOLAR VENTILATOR
    K Number
    K881482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hamilton Medical, Inc.
    Date Received
    April 8, 1988
    Decision Date
    June 16, 1988
    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
    K040574 GALILEO GOLD
    K001686 GALILEO VENTILATOR
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    K960359 ALADDIN MONITORING OXYGEN/AIR MIXER
    K945740 INFANT FLOW SYSTEM
    K901448 VEOLAR VENTILATOR
    K900465 MAX TRANSPORT VENTILATOR
    K894426 LEONARDO INFORMATION SYSTEM
    K894316 AMADEUS VENTILATOR
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