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

    CERYX PACEMAKER MODELS 114, 314 & 614

    K Number: K854790 · Decision Aug 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    19
    Review Days
    272

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    Basic Information

    Device Name
    CERYX PACEMAKER MODELS 114, 314 & 614
    K Number
    K854790
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vitatron Medical BV
    Date Received
    November 29, 1985
    Decision Date
    August 28, 1986
    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 Vitatron Medical BV

    K Number Device Name
    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
    K831860 GENERATOR, PULSE, PACEMAKER #532
    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 →