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510(k) Data Aggregation
K Number
K142503Device Name
IMED-Z FLUID STATUS MONITOR
Manufacturer
INTERSECTION MEDICAL, INC.
Date Cleared
2015-06-05
(273 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
INTERSECTION MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMED-Z Fluid Status Monitor is intended for patients:
- With fluid management problems
- Taking diuretic medication
- Living with Heart Failure ●
- Living with End-stage Renal Disease ●
- Recovering from Coronary artery Disease related event ●
- o Suffering from Recurrent Dehydration
This device is intended for use, under the direction of a physician, for the noninvasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Device Description
The IMED-Z Fluid Status Monitor is a non-invasive, battery-powered impedance monitor designed as an "early warning" monitor for determining changes in the fluid status of patients with fluid management problems. The IMED-Z Fluid Status Monitor works by applying a low-amplitude, high frequency electrical current to the body and measuring the electrical impedance using a four-point measurement technique through hydrogel (ECG style) electrode contacts. Base Impedance, also known as Zo, decreases when fluid increases and increases when fluid decreases. The Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Intersection Medical, Inc. IMED-approved electrodes must be used with the IMED-Z Fluid Status Monitor. Zo reading obtained from unapproved electrodes may not be accurate.
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