BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VIVAPORE 10

    K Number: K943965 · Decision Apr 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    14
    Applicant Total
    3
    Review Days
    257

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    Basic Information

    Device Name
    VIVAPORE 10
    K Number
    K943965
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vivascience, Inc.
    Date Received
    July 28, 1994
    Decision Date
    April 11, 1995
    Product Code
    JJH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJH Clinical Sample Concentrator

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