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

    THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM

    K Number: K010692 · Decision Jun 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    10
    Review Days
    113

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    Basic Information

    Device Name
    THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
    K Number
    K010692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spintech, Inc.
    Date Received
    March 8, 2001
    Decision Date
    June 29, 2001
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Spintech, Inc.

    K Number Device Name
    K223079 Stage
    K210843 STAGE
    K173224 SPIN-SWI
    K023722 SAFETYWAND DISPOSABLE HANDPIECE
    K992404 THE WAND
    K992819 WAND PLUS
    K961648 THE WAND
    K955654 SHORTSTOP DISPOSABLE PROPHY ANGLE
    K922238 LEAPLAZA FRAME