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

    PRONEB ULTRA MODEL NUMBER 85B0100

    K Number: K002862 · Decision Mar 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    181

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    Basic Information

    Device Name
    PRONEB ULTRA MODEL NUMBER 85B0100
    K Number
    K002862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pari Holding Co.
    Date Received
    September 13, 2000
    Decision Date
    March 13, 2001
    Product Code
    BTI
    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
    BTI Compressor, Air, Portable

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