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

    LEAD MODIFICATION

    K Number: K770135 · Decision Feb 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    11
    Review Days
    14

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    Basic Information

    Device Name
    LEAD MODIFICATION
    K Number
    K770135
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Elema-Schonander, Inc.
    Date Received
    January 24, 1977
    Decision Date
    February 7, 1977
    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 Elema-Schonander, Inc.

    K Number Device Name
    K934944 MPQ-42
    K904103 SEP 90
    K903576 PUCK 90M
    K842903 SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
    K842911 PUCK U & UD CUTFILM CHANGERS
    K840389 SEP PROGRAMMER SEP-M/SINGLE-PLANE &
    K790792 PULSE GENERATOR MODEL 637
    K790670 PULSE GENERATOR MODEL 629
    K781178 PULSE GENERATOR MODEL 208
    K770005 PACEMAKER 208S
    Search all 11 clearances from Elema-Schonander, Inc. →