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510(k) Data Aggregation

    K Number
    K963631
    Device Name
    SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
    Manufacturer
    OMEGA RESULTS
    Date Cleared
    1997-04-02

    (203 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMEGA RESULTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is indicated for use under the supervision of a Physician. This product is indicated for use in the computer aided scoring of sleep study recordings.
    Device Description
    Not Found
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