BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Somfit D

    K Number: K252383 · Decision Aug 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    9
    Review Days
    28

    Basic Information

    Device Name
    Somfit D
    K Number
    K252383
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compumedics Limited
    Date Received
    July 31, 2025
    Decision Date
    August 28, 2025
    Product Code
    MNR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    NE
    Third Party
    Y

    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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