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

    SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

    K Number: K070795 · Decision Aug 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
    K Number
    K070795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atcor Medical Pty, Ltd.
    Date Received
    March 22, 2007
    Decision Date
    August 31, 2007
    Product Code
    DSK
    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
    DSK Computer, Blood-Pressure

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    Other Clearances by Atcor Medical Pty, Ltd.

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