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510(k) Data Aggregation

    K Number
    K233580
    Device Name
    A Breathing System (ABS)
    Manufacturer
    DeepWell DTx Inc.
    Date Cleared
    2024-08-01

    (268 days)

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

    DeepWell DTx Inc.

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