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

    VOYAGER PX

    K Number: K895082 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    148

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    Basic Information

    Device Name
    VOYAGER PX
    K Number
    K895082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5655
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Smith-Perry Corp.
    Date Received
    August 14, 1989
    Decision Date
    January 9, 1990
    Product Code
    BYJ
    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
    BYJ Unit, Liquid-Oxygen, Portable

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    Other Clearances by Smith-Perry Corp.

    K Number Device Name
    K884754 VOYAGER/X