BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    VITALOGRAPH MODEL 7100 - VITALOJAK

    K Number: K110525 · Decision Nov 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    7
    Review Days
    273

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    Basic Information

    Device Name
    VITALOGRAPH MODEL 7100 - VITALOJAK
    K Number
    K110525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalograph (Ireland) , Ltd.
    Date Received
    February 23, 2011
    Decision Date
    November 23, 2011
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Vitalograph (Ireland) , Ltd.

    K Number Device Name
    K160253 Vitalograph Model 6300 micro
    K142642 Vitalograph Model 6600 Compact
    K142812 Vitalograph Model 6800 Pneumotrac
    K141546 VITALOGRAPH MODEL 7000 SPIROTRAC
    K100687 VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
    K073155 VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)