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

    CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM

    K Number: K011324 · Decision May 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    17
    Review Days
    22

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    Basic Information

    Device Name
    CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
    K Number
    K011324
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cambridge Heart, Inc.
    Date Received
    May 1, 2001
    Decision Date
    May 23, 2001
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Cambridge Heart, Inc.

    K Number Device Name
    K100362 CAMBRIDGE HEART OEM
    K050225 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
    K022152 HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
    K022149 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
    K013564 MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
    K013565 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
    K012206 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
    K010758 HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
    K010756 CH 2000 CARDIAC DIAGNOSTIC SYSTEM
    K003492 ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS
    Search all 17 clearances from Cambridge Heart, Inc. →