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

    SANSA HSAT

    K Number: K250882 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    4
    Review Days
    219

    Basic Information

    Device Name
    SANSA HSAT
    K Number
    K250882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huxley Medical
    Date Received
    March 24, 2025
    Decision Date
    October 29, 2025
    Product Code
    MNR
    Advisory Committee
    Anesthesiology
    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
    MNR Ventilatory Effort Recorder

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    Other Clearances by Huxley Medical

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