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510(k) Data Aggregation
K Number
K152801Device 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
870.1120Why 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
K122365Device Name
ULTRACHECK CURVE BLOOD PRESSURE CUFFS
Manufacturer
STATCORP MEDICAL
Date Cleared
2013-06-04
(302 days)
Product Code
OED
Regulation Number
870.1120Why 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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