BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRESSUREALERT® Pressure Monitoring System

    K Number: K233096 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    PRESSUREALERT® Pressure Monitoring System
    K Number
    K233096
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Position Health, LLC
    Date Received
    September 26, 2023
    Decision Date
    June 21, 2024
    Product Code
    SBO
    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
    SBO Bed-Patient Activity Monitoring System