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510(k) Data Aggregation
K Number
K022660Device Name
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
Manufacturer
BIOCHECK, INC.
Date Cleared
2002-12-19
(132 days)
Product Code
DRR
Regulation Number
870.2050Why did this record match?
Product Code :
DRR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioCheck Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
Device Description
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K Number
K971570Device Name
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
Manufacturer
QUINTON ELECTROPHYSIOLOGY CORP.
Date Cleared
1997-12-29
(244 days)
Product Code
DRR
Regulation Number
870.2050Why did this record match?
Product Code :
DRR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision) is the acquisition, amplification, display, recording, and transmission of electrical signals of biological origin obtained during electrophysiology studies and related procedures. Such signals include ECG, intracardiac ECG, and blood pressure. Physiological parameters as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from these signals and displayed numerically, recorded, and/or transmitted.
Additionally, the EPXpress System (Timberwolf Revision) may acquire, transpose, amplify, display, record and transmit measurement data received from other medical devices typically used during these procedures, such as oximeters, RF generators, or electronic thermometers.
Device Description
The EPXpress System (Timberwolf Revision) is an integrated catheter switching amplification and display system that can be installed at the patient table in the electrophysiology lab or moved to other locations where particular procedures may require its use. The system is made up of the EPAmp, Real-Time Controller, and monitor that are usually mounted on a cart. The EPAmp unit amplifies and conditions electrical signals from intracardiac catheters and displays these signals on a real-time monitor and/or prints these results to a chart recorder. The Timberwolf Revision added the capability of numerically displaying diastolic, systolic and mean blood pressures, as well as heart rate, cycle length, and certain measurement data received from other instruments.
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