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510(k) Data Aggregation
K Number
K100237Device Name
DIALYSATE METER, MODEL D-6
Manufacturer
MYRON L COMPANY
Date Cleared
2010-04-23
(87 days)
Product Code
FLB
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MYRON L COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Myron L Company D-6 Dialysate Meter™ is a hand-held, multi-test instruments that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors. It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems. D-6 Dialysate Meter is intended for the above uses where: a. The measurement of conductivity, resistivity, TDS, pH is needed and; b. The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of oxidizing or reducing agents in product water or treated wastewater.
Device Description
The D-6 Dialysate Meter™ is a microprocessor-based, battery powered, handheld, device that measures conductivity, resistivity total dissolved solids (TDS), pH, Temperature, and oxidation-reduction potential (ORP) of water and dialysate fluids associated with hemodialysis delivery systems. It measures and reports multiple ranges of conductivity, resistivity, TDS, pH and ORP. All measurement functions are automatically compensated for temperature. Up to 100 measurements can be stored in the devices memory, including the measured value, temperature and the date/time the measurement was taken. The device comes in a waterproof, chemically resistant case.
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