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

    GENERATOR, PULSE, PACEMAKER #532

    K Number: K831860 · Decision Oct 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    19
    Review Days
    139

    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
    GENERATOR, PULSE, PACEMAKER #532
    K Number
    K831860
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vitatron Medical BV
    Date Received
    June 10, 1983
    Decision Date
    October 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 Vitatron Medical BV

    K Number Device Name
    K854790 CERYX PACEMAKER MODELS 114, 314 & 614
    K844484 HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
    K844483 TP 1
    K844485 CERYX6, 611, CERYX 3 311 & CERYX 1 111
    K840668 ELECTRODE PACEMAKER, PERM & TEMP
    K831859 PACEMAKER PROGRAMMER #2032
    K810928 ENDOCARDIAL ELECTRODE
    K791920 CARDIAC PACEMAKER P4000 SER. & P1000
    K791921 CARDIAC PACEMAKER C4000, C1000 SER.
    K791380 VA 1000
    Search all 19 clearances from Vitatron Medical BV →