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

    SYSTEM I INFANT MONITORING SYS

    K Number: K820943 · Decision May 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    SYSTEM I INFANT MONITORING SYS
    K Number
    K820943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Burr Engineering & Development Co.
    Date Received
    April 6, 1982
    Decision Date
    May 3, 1982
    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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