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

    SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09

    K Number: K032981 · Decision Apr 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    1
    Review Days
    211

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    Basic Information

    Device Name
    SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
    K Number
    K032981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invamed Technologies, Inc.
    Date Received
    September 24, 2003
    Decision Date
    April 22, 2004
    Product Code
    BSP
    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
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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