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

    CARDIO PERFECT ST 2001

    K Number: K935732 · Decision Apr 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    4
    Review Days
    855

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    Basic Information

    Device Name
    CARDIO PERFECT ST 2001
    K Number
    K935732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio Control BV
    Date Received
    December 1, 1993
    Decision Date
    April 4, 1996
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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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
    K922898 CARDIO PERFECT, CARDIO PERFECT MD
    K913374 CARDIO PERFECT, CARDIO PERFECT MD