BEUDAMED
    Product Code: PDR FDA class 3

    Computer-Assisted Personalized Sedation System

    Unknown

    The Computer-Assisted Personalized Sedation System is an automated device that administers a sedative drug while continuously monitoring the patient's depth of sedation and providing monitoring and alarms for physiological parameters during medical procedures. It is classified as a Class 3 device, the highest risk category requiring Premarket Approval (PMA) to demonstrate safety and effectiveness, with no specific regulation number assigned. Class 3 classification reflects the significant risks associated with automated drug delivery and sedation management. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PDR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.