(202 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Not Found
This redacted FDA 510(k) summary only includes the formal letter approving the device for market, the device's indications for use, and a cover sheet. It does NOT contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot provide the requested information.
§ 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).