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510(k) Data Aggregation
K Number
K112269Device Name
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
Manufacturer
Date Cleared
2011-10-20
(73 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
OSTAR MEDITECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper arm.
The cuff circumference is limited to be 5.5'~7.8'(14 cm ~20 cm) for wrist type, and 9'~13'(24cm ~32cm) for Upper Arm Type.
Device Description
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100 use the Oscillometric method to measure blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to ise the stethoscope, as in the traditional measuring method, to monitor the Korothkov sound when deciding the systolic and diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating stop decreasing. In addition, the heart beat rate will be also measured and displayed on LCD as part of measurement result.
For P200 Upper Arm Type, all the measuring circuit, measuring devices, measuring and display software are all mounted on the device housing. It can be operated individually or be operated by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.
For M100 Wrist Type. all the measuring circuit, measuring devices, software are all mounted on the device housing except for the measurement control keys and display. It can be operated only by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.
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K Number
K050680Device Name
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
Manufacturer
Date Cleared
2005-05-13
(58 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
OSTAR MEDITECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ostar A2, and K7 are indicated for trained medical professionals to operate on the patient at clinical settings to collect and measure blood pressure, pulse rate noise index and pressure waveform diagram (including heartbeat waveform and noise waveform). In addition, the Ostar P2 and X2 are indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider. P2 and X2 do not display the measuring waveform.
The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Device Description
Basically the measuring system were composite of blood pressure measuring circuit via Dacillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero measuring our at unfine inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :
- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
- Heart beat rate.
- Heart beat noise calculated via FFT ( Fast Fourier Transformation).
For the display of measuring results and operation interface, the following difference were provided for the following different models :
- For model A2, RS 232 is provided for the connection with PC for the measurement operation and display of the whole measuring pressure waveform, noise waveform, systolic and diastolic pressure, heat beat rate, and noise index.
- For model K7, the operation and display details are completely identical to that of model A2.
- For model X2 and P2, all the measurement components are mounted within a compact housing with operation key and display LCD. These two models do not display the measurement waveform and noise waveform, but they could display the measurement results of systolic and diastolic pressure, heat beat rate, and noise index.
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