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

    PV01 PVDF Effort Sensor

    K Number: K251480 · Decision Aug 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    108

    Basic Information

    Device Name
    PV01 PVDF Effort Sensor
    K Number
    K251480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurotronics, LLC
    Date Received
    May 13, 2025
    Decision Date
    August 29, 2025
    Product Code
    SFK
    Advisory Committee
    Neurology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFK Respiratory Effort Belt For Polysomnography