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

    AMS 3000M

    K Number: K936009 · Decision May 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    12
    Review Days
    503

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    Basic Information

    Device Name
    AMS 3000M
    K Number
    K936009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acutronic Medical Systems AG
    Date Received
    December 16, 1993
    Decision Date
    May 3, 1995
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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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
    K900745 VS-200S JET VENTILATOR
    K900744 AMS 3000 PORTABLE JET VENTILATOR
    K883865 EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
    K863155 UNIVERSAL JET VENTILATOR MODEL AMS-1000
    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 →