BEUDAMED
    Product Code: QOG FDA class 2 21 CFR 880.5860

    Injection Data Capture Device

    General Hospital

    The Injection Data Capture Device is an electrically-powered or electromechanical accessory that interfaces with reusable or disposable injection devices to interpret, record, display, and/or transmit injection data to a connected application or software platform. It is used to improve adherence monitoring and injection logging in clinical or patient self-care settings. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5860 in the General Hospital specialty. It carries product code QOG and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    3

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    Basic Information

    Product Code
    QOG
    Device Class
    FDA class 2
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K243901 SmartPilot YpsoMate NS-A2.25
    K251500 MallyaG Injection Pen Adapter (MallyaG)
    K250555 MallyaD injection pen adapter (MallyaD)
    K241803 INSULCLOCK® v2.0 PRO
    K231820 SoloSmart Injection Pen Adapter (SoloSmart®)
    K222689 Mallya Injection Pen Adapter (Mallya® for Solostar®)
    K212217 Tempo Smart Button

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.