(209 days)
Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The theoretical range of cuff circumference is limited to 14-19.5cm.
Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series
The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Type Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.
Therefore, I cannot provide the requested information from the given input. The letter primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory compliance requirements. It does not delve into the specific technical performance or study results.
§ 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).