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510(k) Data Aggregation
K Number
K133301Device Name
ZOE FLUID STATUS MONITOR
Manufacturer
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2014-01-22
(89 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZOE 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, Suffering from Recurrent Dehydration. This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Device Description
The ZOE Fluid Status Monitor Model ZOE3 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 ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
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K Number
K131509Device Name
ZOE FLUID STATUS MONITOR
Manufacturer
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2013-06-28
(35 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZOE 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 . - Suffering from Recurrent Dehydration . This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Device Description
The ZOE 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 ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!
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K Number
K112830Device Name
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
Manufacturer
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2012-11-13
(412 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZOE 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
- Suffering from Recurrent Dehydration
This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Device Description
The ZOE 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 ZOE Fluid Status Monitor works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.
The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver chloride electrodes that are readly available / commercially approved within the United States for other approved cardiovascular monitoring systems.
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