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

    I.V. SENTRY ALARM DEVICE

    K Number: K802101 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    I.V. SENTRY ALARM DEVICE
    K Number
    K802101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pike Medical Co.
    Date Received
    September 3, 1980
    Decision Date
    September 16, 1980
    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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