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510(k) Data Aggregation
K Number
K021029Device Name
ABP-2000 G-3
Manufacturer
Date Cleared
2002-04-12
(14 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
BIOTRAC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment's follow-up when it is necessary to measure a patient's blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed:
- for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human beings.
- for recording during a predetermined period of time the above mentioned measurements (up to 250 measurements).
- to be used along with the ABP-2000 G-3 software for programming as well as record keeping and display in a graphical or tabular report.
Device Description
The ABP-2000 G-3 is an automated, ambulatory, non-invasive blood pressure (NIBP) monitor microprocessor based. The device uses an oscillometric linear deflation technique to determine blood pressure. A cuff is inflated by an internal electrical air pump, and the deflation process is controlled by two internal valves. During deflation, the arterial blood pressure pulses are sensed by the device by means of cuff pressure changes, which are analyzed by the microprocessor in order to determine the blood pressure. The ABP-2000 G-3 can record patient's blood pressure at different and previously determined intervals as clinically scheduled, or can be activated by pressing the Start/Stop button.
The physician can program the measurement intervals as well as the LCD display (it can be disabled to prevent patient from seeing the readings) and then, the device is placed on the patient at the physician's office and is usually worn for 24 hours. The ABP-2000 G-3 software allows the physician to setup the device, the display and to keep all the records. The information is stored on an internal memory that will register each reading. All the data can be downloaded (via serial cable) into the computer software once the study has ended. The information can be analyzed and presented in either graphical or table format, and printed in either format using the PC software.
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