BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇳🇱 Netherlands

    HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA

    K Number: K844484 · Decision Jul 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    24
    Applicant Total
    19
    Review Days
    247

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    Basic Information

    Device Name
    HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
    K Number
    K844484
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vitatron Medical BV
    Date Received
    November 19, 1984
    Decision Date
    July 24, 1985
    Product Code
    KRG
    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
    KRG Programmer, Pacemaker

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    Other Clearances by Vitatron Medical BV

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    K840668 ELECTRODE PACEMAKER, PERM & TEMP
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    K831860 GENERATOR, PULSE, PACEMAKER #532
    K810928 ENDOCARDIAL ELECTRODE
    K791920 CARDIAC PACEMAKER P4000 SER. & P1000
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