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

    NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN

    K Number: K123766 · Decision Aug 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    14
    Review Days
    251

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    Basic Information

    Device Name
    NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
    K Number
    K123766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novo Nordisk, Inc.
    Date Received
    December 7, 2012
    Decision Date
    August 15, 2013
    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 Novo Nordisk, Inc.

    K Number Device Name
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    K173479 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
    K162602 NovoPen Echo
    K150874 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
    K133738 NOVOFINE PLUS 32G 4 MM
    K093109 NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
    K090111 FLEXPEN NEEDLE
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