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510(k) Data Aggregation
K Number
K022047Device Name
PHLEBOTEST 2000
Manufacturer
OSBORN MEDICAL CORP.
Date Cleared
2002-11-04
(133 days)
Product Code
JOM
Regulation Number
870.2780Why did this record match?
Applicant Name (Manufacturer) :
OSBORN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Phlebotest 2000 is a system for peripheral vascular diagnostic investigations.
Outflow phethysmography (OP)
Passive Drain and Refill (PDR)
Exercise Venous Plethysmography (EVP)
Triple Test (TTT) Combination of OP, PDR, and EVP
Either Strain Gauges or Air Pressure Cuffs
Prescription device by a physician
Device Description
The PHLEBOTEST 2000 is a system designed for peripheral vascular diagnostic investigations. The center of the system is a specially developed patient chair, which can be positioned according to the investigation performed. The patient can be in a sitting or laying position, with legs positioned in different angels using the movable heel and foot support. Patient elevation between laying and sitting positions can be carried out in various speeds according to investigational requirements. All movements are carried out with low-voltage electrical motors and are directed by a remote hand controller. A pneumatic system consisting of a compressor, pressure tank and valve system is integrated in the system. Different sensors can be attached to the patients for measuring the various examination possibilities. The sensors and pneumatic system are fully integrated and controlled by hardware and software in connection with a PC Windows-based computer. A number of special developed software programs for various diagnostic tests support the system.
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K Number
K960963Device Name
CORD WRAP WITH NEEDLE RESHEATHER
Manufacturer
OSBORN MEDICAL CORP.
Date Cleared
1996-05-06
(56 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
OSBORN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cord Wrap with Needle Resheather (Model CN-34) is an accessory to Infusion Stands, Classification (80 FOX).
Device Description
The Cord Wrap with Needle Resheather comprises a reel for storing electric cords at a pole-type infusion stand. The stand provides a pole stanchion that extends a number of feet and supports an infusion pump and/or bags or bottles of liquid infusants. The Cord Wrap is constructed to conveniently store the electric cord of the infusion pump at the pole during and between use. The cord is coiled about an elongated spool which is retained on the pole via a clamp assembly. The clamp assembly includes a hand wheel and threaded hook arm. The hook arm mounts about the pole, and upon tightening of the hand wheel the hook arm is drawn tight to the infusion stand. Two protrusions are aligned to the hook arm and form a channel space where the infusion stand can nest. The Cord Wrap with Needle Resheather is thereby prevented from rotating about the pole. The position of the Cord Wrap with Needle Resheather along the infusion stand can be varied by loosening the hand wheel and moving the Cord Wrap with Needle Resheather either up or down the infusion stand and retightening the hand wheel. Protruding from the Cord Wrap with Needle Resheather is a needle holder which contains five cavities to receive and retain several cover pieces of needle storage containers. The five cavities are constructed to receive and hold the cover piece. This permits the staff member to de-couple the needle body from the cover with a single hand. The Cord Wrap, hand wheel, and Needle Resheather are molded from a resin Acrylonitrile-Butadiene-Styrene (ABS). The Needle Resheather is glued to the Cord Wrap with Loctite® 494 adhesive. The threaded hook arm is made of stainless steel. The Cord Wrap with Needle Resheather is packaged assembled in polyethylene bags.
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