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510(k) Data Aggregation
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?
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
K071885Device Name
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
Manufacturer
PHILIPS MEDICAL SYSTEMS
Date Cleared
2007-12-20
(164 days)
Product Code
OED
Regulation Number
870.1120Why 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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