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

    CARDIO-CARD ECG MANAGEMENT SYSTEM

    K Number: K920020 · Decision Jul 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    5
    Review Days
    189

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    Basic Information

    Device Name
    CARDIO-CARD ECG MANAGEMENT SYSTEM
    K Number
    K920020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nasiff Assoc., Inc.
    Date Received
    January 2, 1992
    Decision Date
    July 9, 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 Nasiff Assoc., Inc.

    K Number Device Name
    K993616 CARDIO-CARD INTERPRETATION SYSTEM I
    K972795 CARDIO-CARD MANAGEMENT SYSTEM II
    K960544 CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
    K903722 MICROMED QRS CARD