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

    Vitalograph Model 6300 micro

    K Number: K160253 · Decision Aug 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    207

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    Basic Information

    Device Name
    Vitalograph Model 6300 micro
    K Number
    K160253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalograph (Ireland) , Ltd.
    Date Received
    February 1, 2016
    Decision Date
    August 26, 2016
    Product Code
    BZG
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZG Spirometer, Diagnostic

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    Other Clearances by Vitalograph (Ireland) , Ltd.

    K Number Device Name
    K142642 Vitalograph Model 6600 Compact
    K142812 Vitalograph Model 6800 Pneumotrac
    K141546 VITALOGRAPH MODEL 7000 SPIROTRAC
    K110525 VITALOGRAPH MODEL 7100 - VITALOJAK
    K100687 VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
    K073155 VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)