(302 days)
BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound the blood flowing from the wound in pressurizing.
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This document is a 510(k) premarket notification for the BW-BW1 Bluetooth Blood Pressure Monitor. It primarily consists of regulatory correspondence and an "Indications for Use" statement, and does not contain the detailed study information needed to answer the request.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, because this document does not include that data. This document only states that the device is "substantially equivalent" to predicate devices, which is part of the regulatory approval process but doesn't detail performance studies.
§ 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).