BEUDAMED
    Product Code: LME FDA class 3

    Monitor, Blood-Flow, Cerebral, Thermal Diffusion

    Unknown

    Monitor, Blood-Flow, Cerebral, Thermal Diffusion is a monitoring device that uses the thermal diffusion principle to measure cerebral blood flow, providing continuous or intermittent assessment of regional brain perfusion in critical care or neurosurgical settings, where compromised cerebral blood flow indicates risk of ischemic injury. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LME; no regulation number has been assigned. The review panel is Neurology.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Research product code LME in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    LME
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    3

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K850657 THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR