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510(k) Data Aggregation
K Number
K001763Device Name
CRIT-LINE MONITOR III (CLM III)
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
2000-12-20
(191 days)
Product Code
MQS
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992227Device Name
CRIT-LINE MONITOR III (CLM III)
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
1999-07-30
(28 days)
Product Code
MQS
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRIT-LINE MONITOR III, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
Device Description
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
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K Number
K983551Device Name
CRIT-SCAN II MONITOR
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
1999-05-27
(230 days)
Product Code
GKF, MAR
Regulation Number
864.5600Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the CRIT-SCAN II Monitor is as a continuous, non-invasive hematocrit-measuring device whereby a physician could use the information to determine the anemic state of the patient.
The intended use of the CRIT-SCAN II Monitor is as a hematocrit-measuring device.
Device Description
The CRIT-SCAN II consists of state-of-the-art optoelectronics which, when combined with custom software, has the ability to measure hematocrit transcutaneously (i.e. through a patient's middle finger or index finger). The patient's finger is placed into a custom designed cuff which, when filled with air, creates the necessary perfusion for the optoelectronics to take a hematocrit reading.
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K Number
K982412Device Name
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
1998-10-09
(88 days)
Product Code
MQS
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
Device Description
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
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K Number
K972470Device Name
CRIT-LINE MONITOR (CLMIII)
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
1997-12-11
(163 days)
Product Code
MQS
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Device Description
The CLMIII consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber.
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K Number
K953875Device Name
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
Manufacturer
IN-LINE DIAGNOSTICS CORP.
Date Cleared
1996-07-23
(391 days)
Product Code
MQS
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
IN-LINE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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