(102 days)
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arm Electronic Blood Pressure Monitor:
The document provides a 510(k) summary for the Andon Health Co., Ltd. Arm Electronic Blood Pressure Monitor. It asserts substantial equivalence to previously marketed devices and references compliance with certain standards for performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standard: ANSI/AAMI SP-10 standard | Device meets ANSI/AAMI SP-10 standard |
| Safety Standard: EN60601-1 Medical electrical equipment Part 1: General requirements for safety | Device meets EN60601-1 |
| EMC Standard: EN60601-1-2 Electromagnetic Compatibility | Device meets EN60601-1-2 |
| Intended Use: For use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time. | Device intended for this use and functions, as evidenced by compliance with performance standards. |
| Cuff Circumference: Limited to 22cm-48cm (comprised of 3 cuffs: 22-30cm, 30-42cm, 42-48cm) | Device supports this range with specified cuffs. |
| Cuff Pressure Range: 0-300mmHg (for KD-322, KD-622 and KD-575) | Device functions within this range. |
| Humidity (Operational): |
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).