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510(k) Data Aggregation
K Number
K063863Device Name
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
Manufacturer
ADVANTAGE MEDICAL CABLES, INC.
Date Cleared
2007-03-20
(82 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE MEDICAL CABLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIBP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.
Device Description
The Advantage Cuff, NIBP Hose and Adapters are accessories for noninvasive blood pressure systems. Cuff: The cuff is comprised of an air tight bladder enclosed in an inelastic sleeve with one or two tubes and the appropriate connectors for the type device required. The Advantage Cuffs come in a range of sizes, each marked with the appropriate limb circumference for which the cuff is intended. Hose: The hose is comprised of single or dual tubing, in various lengths as required by the customer or application, with the appropriate connectors attached to each end of the tubing. Adapters: The adapters are comprised of short pieces of tubing in a "Y" configuration primarily to adapt a single tube cuff to a dual tube hose or a dual tube cuff to a single tube hose as required by the customer.
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