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

    360D DC DEFIBRILLATOR

    K Number: K874091 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    10
    Review Days
    47

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    Basic Information

    Device Name
    360D DC DEFIBRILLATOR
    K Number
    K874091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medac, Inc.
    Date Received
    October 7, 1987
    Decision Date
    November 23, 1987
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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    Other Clearances by Medac, Inc.

    K Number Device Name
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    K874090 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER
    K871176 PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
    K864985 DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
    K864986 ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
    K864988 ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
    K864989 ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
    K864987 DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE