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

    PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

    K Number: K910029 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    46
    Review Days
    28

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    Basic Information

    Device Name
    PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
    K Number
    K910029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Spacelabs, Inc.
    Date Received
    January 3, 1991
    Decision Date
    January 31, 1991
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXK Echocardiograph

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