(52 days)
KD-931D Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals 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 arm. The cuff circumference is limited to 22cm-48cm.
KD-931D Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals 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 arm. The cuff circumference is limited to 22cm-48cm. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it also has the function of averaging the last three measurements. Compared to KD-556, KD-931D does not contain an LCD, it will display the measurement result on the iPhone which is connected to the device.
Here's a breakdown of the acceptance criteria and study information for the KD-931D Fully Automatic Electronic Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The KD-931D Fully Automatic Electronic Blood Pressure Monitor states Performance: Similar when compared to its predicate device, KD-556. Both devices are designed and manufactured according to ANSI/AAMI SP10, which specifies performance requirements for manual, electronic, or automated sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference, standard deviation) are not explicitly stated in the provided text as a table, the device's conformance to AAMI SP10:2002 and its amendments implies meeting the accuracy standards outlined in that standard.
Implied Acceptance Criteria (based on AAMI SP10 compliance):
| Parameter | Acceptance Criteria (from AAMI SP10) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy (Systolic & Diastolic) | Mean Difference: |
§ 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).