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

    MONITORING KIT AMK-1

    K Number: K830778 · Decision Oct 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    217

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    Basic Information

    Device Name
    MONITORING KIT AMK-1
    K Number
    K830778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Alternative Design Systems, Inc.
    Date Received
    March 11, 1983
    Decision Date
    October 14, 1983
    Product Code
    FLS
    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
    FLS Monitor, Apnea, Facility Use

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