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

    HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

    K Number: K022152 · Decision Jul 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    17
    Review Days
    14

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    Basic Information

    Device Name
    HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
    K Number
    K022152
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cambridge Heart, Inc.
    Date Received
    July 2, 2002
    Decision Date
    July 16, 2002
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    K010758 HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
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    K003492 ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS
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