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

    CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM

    K Number: K960544 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    5
    Review Days
    182

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    Basic Information

    Device Name
    CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
    K Number
    K960544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nasiff Assoc., Inc.
    Date Received
    February 7, 1996
    Decision Date
    August 7, 1996
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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    Other Clearances by Nasiff Assoc., Inc.

    K Number Device Name
    K993616 CARDIO-CARD INTERPRETATION SYSTEM I
    K972795 CARDIO-CARD MANAGEMENT SYSTEM II
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