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510(k) Data Aggregation

    K Number
    K233337
    Device Name
    Freespira Breathing System
    Manufacturer
    Freespira, Inc
    Date Cleared
    2025-04-24

    (573 days)

    Product Code
    SEN
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Freespira, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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