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

    HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT

    K Number: K962854 · Decision Jan 27, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    4
    Review Days
    189

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    Basic Information

    Device Name
    HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
    K Number
    K962854
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardio Control BV
    Date Received
    July 22, 1996
    Decision Date
    January 27, 1997
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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    Other Clearances by Cardio Control BV

    K Number Device Name
    K935732 CARDIO PERFECT ST 2001
    K922898 CARDIO PERFECT, CARDIO PERFECT MD
    K913374 CARDIO PERFECT, CARDIO PERFECT MD