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510(k) Data Aggregation

    K Number
    K061962
    Device Name
    SURGI-CUF REUSABLE, RS SERIES
    Date Cleared
    2006-07-25

    (13 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHOX INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
    Device Description
    The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems. Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations: Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh) Single Tube configuration with 6 types of connectors Double Tube configuration with 2 types of connectors
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