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

    AlertWatch: OR

    K Number: K153335 · Decision Mar 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    301
    Applicant Total
    2
    Review Days
    117

    Basic Information

    Device Name
    AlertWatch: OR
    K Number
    K153335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ALERTWATCH LLC
    Date Received
    November 19, 2015
    Decision Date
    March 15, 2016
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by ALERTWATCH LLC

    K Number Device Name
    K130401 ALERTWATCH: OR