BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    CARDIO PERFECT, CARDIO PERFECT MD

    K Number: K913374 · Decision Jan 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    4
    Review Days
    178

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    Basic Information

    Device Name
    CARDIO PERFECT, CARDIO PERFECT MD
    K Number
    K913374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardio Control BV
    Date Received
    July 29, 1991
    Decision Date
    January 23, 1992
    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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    Other Clearances by Cardio Control BV

    K Number Device Name
    K962854 HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
    K935732 CARDIO PERFECT ST 2001
    K922898 CARDIO PERFECT, CARDIO PERFECT MD