BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    UNIVERSAL JET VENTILATOR MODEL AMS-1000

    K Number: K863155 · Decision Sep 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    12
    Review Days
    409

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    Basic Information

    Device Name
    UNIVERSAL JET VENTILATOR MODEL AMS-1000
    K Number
    K863155
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Acutronic Medical Systems AG
    Date Received
    August 15, 1986
    Decision Date
    September 28, 1987
    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 Acutronic Medical Systems AG

    K Number Device Name
    K012691 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    K012693 MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
    K936009 AMS 3000M
    K900745 VS-200S JET VENTILATOR
    K900744 AMS 3000 PORTABLE JET VENTILATOR
    K883865 EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
    K863154 HEATED JET HUMIDIFIER MODEL AMS-1020
    K862436 TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
    K862435 DOUBLE LUMEN E T ADAPTOR
    K862433 UNI-JET CONNECTOR
    Search all 12 clearances from Acutronic Medical Systems AG →