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510(k) Data Aggregation

    K Number
    K122365
    Device Name
    ULTRACHECK CURVE BLOOD PRESSURE CUFFS
    Manufacturer
    STATCORP MEDICAL
    Date Cleared
    2013-06-04

    (302 days)

    Product Code
    OED
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    OED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure. UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
    Device Description
    The UltraCheck® Blood Pressure cuffs including the UltraCheck® Curve Cuffs in this 510(k), are applied to a patient limb and can be connected pneumatically to manual or oscillometric manometers to enable non-invasive blood pressure measurements. While the general shape of the other cuffs in the UltraCheck® product line is rectangular, the UltraCheck® Curve Cuffs in this 510(k) are conical in shape. They are made of flexible polymeric material a section of which forms an integrated inflatable bladder. A hook and loop closure system on each cuff may be used to secure the cuff around the patients limb. The cuff is connected pneumatically through a one piece lumen to a Patient Monitor or Sphygmomanometer.
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    K Number
    K071885
    Device Name
    ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Date Cleared
    2007-12-20

    (164 days)

    Product Code
    OED
    Regulation Number
    870.1120
    Why did this record match?
    Product Code :

    OED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integral inflatable bladder that is wrapped around a patient's limb. It is secured by a hook and loop fastener. Device tubing is attached to an NIBP measuring system.
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