BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VOYAGER/X

    K Number: K884754 · Decision Jan 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    VOYAGER/X
    K Number
    K884754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Smith-Perry Corp.
    Date Received
    November 14, 1988
    Decision Date
    January 4, 1989
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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    Other Clearances by Smith-Perry Corp.

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    K895082 VOYAGER PX