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510(k) Data Aggregation

    K Number
    K152801
    Device Name
    ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
    Manufacturer
    STATCORP MEDICAL
    Date Cleared
    2015-10-27

    (29 days)

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

    STATCORP MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure. Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
    Device Description
    The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
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    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?
    Applicant Name (Manufacturer) :

    STATCORP MEDICAL

    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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