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510(k) Data Aggregation
K Number
K012553Device Name
GSIBP BLOOD PRESSURE CUFF
Manufacturer
Date Cleared
2001-08-17
(9 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
GLOBALSHOP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Personnel properly trained in the use of blood pressurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multipatient device. It is available in child through large adult sizes.
Device Description
The device is comprised of one or two tubes attached to an inflatable latex bladder, which is covered with a stitched nylon or cotton cover. The device is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. Sizes will include child through large adult. Each cuff will be packaged in a polyethylene bag.
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