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

    413A NEONATAL MONITOR

    K Number: K800164 · Decision Apr 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    413A NEONATAL MONITOR
    K Number
    K800164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2377
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Xerox Corp.
    Date Received
    January 25, 1980
    Decision Date
    April 10, 1980
    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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    Other Clearances by Xerox Corp.

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