(261 days)
By using oscillometric method, the device measure automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. This device is intended for use on adults for age 18 and above. The cuff size is fit for arm circumference of 22-32 cm. The device has the irregular heartbeat indicator feature. The color bar gives a warning signal with readings. The BPU321 can be compatible with the device of Bluetooth Smart-enabled. All values will be read out in LCD panel.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the Oregon Scientific BLE Upper Arm Blood Pressure Monitor (BPU 321). It confirms substantial equivalence to a legally marketed predicate device. While it mentions the device measures blood pressure and heart rate using an oscillometric method and is intended for adults aged 18 and above, it does not contain the detailed study information or acceptance criteria for device performance.
Therefore, I cannot provide the requested table or comprehensive study details. The letter primarily focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting performance study results.
To fulfill the request, information such as the clinical study protocol, results, and statistical analysis would be required, which are typically found in the full 510(k) submission not included in this document.
§ 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).