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510(k) Data Aggregation

    K Number
    K041590
    Device Name
    AUTODETECT SYRINGE
    Manufacturer
    INDIGO ORB, INC.
    Date Cleared
    2004-06-23

    (9 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDIGO ORB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AutoDetect Syringe is intended for use with an epidural needle for the verification of needle tip placement in the epidural space.
    Device Description
    The AutoDetect Syringe is a spring loaded, loss of resistance syringe used during epidural anesthetic procedures. The device is intended for single-use only.
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