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

    PEDIATRIC MULTI-FUNCTION ELECTRODES

    K Number: K915159 · Decision Feb 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    8
    Review Days
    85

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    Basic Information

    Device Name
    PEDIATRIC MULTI-FUNCTION ELECTRODES
    K Number
    K915159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zmi Corp.
    Date Received
    November 14, 1991
    Decision Date
    February 7, 1992
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Zmi Corp.

    K Number Device Name
    K915100 BRINDLEY & SMITH ET-1000
    K913484 ZOLL D-900 DEFIBRILLATOR
    K911956 ZOLL PD-1400 PACER/DEFIBRILLATOR
    K895032 ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
    K885166 ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES
    K873402 ZOLL NTP-1200 PACER/DEFIBRILLATOR
    K855015 NONINVASIVE TEMP. PACEMAKER NTP-1000