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

    CARDIO-SCOPE MINI MONITOR

    K Number: K831878 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    6
    Review Days
    108

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    Basic Information

    Device Name
    CARDIO-SCOPE MINI MONITOR
    K Number
    K831878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    W.E. Leder Enterprises, Inc.
    Date Received
    June 13, 1983
    Decision Date
    September 29, 1983
    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 W.E. Leder Enterprises, Inc.

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    K830161 ANESTHESIA APATATUS #D-25
    K830159 ANESTHESIA APPARATUS PH-35
    K830160 ANESTHESIA APPARATUS #FO 20S