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510(k) Data Aggregation

    K Number
    K945264
    Device Name
    OPTUS OTOSCOPES
    Manufacturer
    OPTUS, INC.
    Date Cleared
    1996-02-02

    (462 days)

    Product Code
    ERA
    Regulation Number
    874.4770
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953913
    Device Name
    OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    Manufacturer
    OPTUS, INC.
    Date Cleared
    1996-01-22

    (154 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTUS, INC.

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

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