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

    DripAssist Plus

    K Number: K172242 · Decision May 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    303

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    Basic Information

    Device Name
    DripAssist Plus
    K Number
    K172242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shift Labs, Inc.
    Date Received
    July 26, 2017
    Decision Date
    May 25, 2018
    Product Code
    FLN
    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
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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