BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    LITHICRON MODEL 0401, PACEMAKER

    K Number: K791095 · Decision Aug 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    LITHICRON MODEL 0401, PACEMAKER
    K Number
    K791095
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medcor, Inc.
    Date Received
    June 12, 1979
    Decision Date
    August 10, 1979
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Medcor, Inc.

    K Number Device Name
    K792609 LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.
    K802224 QUINTREX 0516 PROG. PULSE GENERATOR SYS
    K802223 QUINTREX 0515 PROGRAMMABLE PULSE GEN.
    K791678 LITHICRON II 0403 IMPLANTABLE PACEMAKER
    K780430 LITHICRON F PROGRAMMABLE PULSE GEN
    K771538 LITHICRON MODEL 3-70C-B PULSE GENERATOR
    K770507 PULSE GENERATOR, LITKICRON MODEL 3-70H