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

    ECHO-PULSE KM555

    K Number: K821736 · Decision Dec 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    178

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    Basic Information

    Device Name
    ECHO-PULSE KM555
    K Number
    K821736
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1240
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Rabar, Inc.
    Date Received
    June 14, 1982
    Decision Date
    December 9, 1982
    Product Code
    GXW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXW Echoencephalograph

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    Other Clearances by Rabar, Inc.

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    K842414 ECHO PULSE BURST