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

    BED ALERT

    K Number: K872522 · Decision Jan 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    208

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    Basic Information

    Device Name
    BED ALERT
    K Number
    K872522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.2040
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Nite Train-R Enterprises, Inc.
    Date Received
    June 25, 1987
    Decision Date
    January 19, 1988
    Product Code
    KPN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPN Alarm, Conditioned Response Enuresis

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    Other Clearances by Nite Train-R Enterprises, Inc.

    K Number Device Name
    K780660 NITE TRAIN'R