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

    SIEMENS-ELMA PULSE GENERATOR #718

    K Number: K830344 · Decision May 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    10
    Review Days
    114

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SIEMENS-ELMA PULSE GENERATOR #718
    K Number
    K830344
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Burditt & Calkins-Siemens-Elema
    Date Received
    February 2, 1983
    Decision Date
    May 27, 1983
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.

    PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPUS S MODEL 4121 AND 4124 PACEMAKERS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PIKOS LP 01, PIKOS LP E01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular
    View all

    Other Clearances by Burditt & Calkins-Siemens-Elema

    K Number Device Name
    K833519 PULSE GENERATOR MODEL 688
    K833155 RAYDEN MEDICAL MINI PULSE VOLUME RECORD
    K823435 MON-A-THERM MYOCARDIAL TEMP. SENSOR
    K823591 AMEDA HAND BREAST PUMP
    K822239 COAXIAL BIPOLAR PACING ELECTRODE
    K821712 INFORMED REMOTE FIELD UNIT MODEL IFM1000
    K803111 ERECTAID
    K802607 TERPERATUR SENSING DEVICE
    K760787 LIBERATOR/STROLLER