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510(k) Data Aggregation
K Number
K032075Device Name
CONDUCTIVITY STANDARD SOLUTION-METERCARE
Manufacturer
IBP INSTRUMENTS GMBH
Date Cleared
2003-09-17
(72 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IBP INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems. MeterCare is an Over-the-Counter product and needs no prescription. The product is for In Vitro use only.
Device Description
The "Conductivity Standard Solution – MeterCare" is a range of high accuracy conductivity standard solutions to calibrate conductivity meters used in dialysis to test the conductivity of dialysate of dialysis machines and water used in hemodialysis applications.
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K Number
K020908Device Name
HDM97
Manufacturer
IBP INSTRUMENTS GMBH
Date Cleared
2002-05-22
(63 days)
Product Code
FIZ
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IBP INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDM97 may be used by hemodialysis personnel to test the conductivity, temperature, pressure and pH of the dialysate solution used with hemodialysis delivering systems. The HDM97 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
Device Description
The HDM97 was developed in 1997 to test conductivity/temperature, pressure and pH in hemodialysis applications. The HDM97 has a large, easy readable 3½ Digital Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 9 key's including On and Off. The software is designed to be logical and easy to use for the user either safe and precise in measurement.
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K Number
K020909Device Name
HDM99
Manufacturer
IBP INSTRUMENTS GMBH
Date Cleared
2002-05-22
(63 days)
Product Code
FIZ
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IBP INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HDM99 may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems.
The HDM99 may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The HDM99 may also be used to test the voltage and alternating signals in hemodialysis delivering systems.
Device Description
The HDM99 was developed in 1990. The first version was called HDM90. 1996 we added the Flow measurement. From this time on the device was called HDM96.
1999 we increased accuracy and software functionality. The device was renamed to HDM99.
The HDM99 has a large, easy readable Graphic Liquid Crystal Display. It comes with a waterproof key membrane. All selections are done with 22 key's including On and Off.
The software is designed to be logical and easy to use for the user either safe and precise in measurement.
The HDM99 has a RS232-Interface for the possibility to collect and visualize data on a PC.
The software is designed to be logical and easy to use for the user either safe and precise in measurement.
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