(120 days)
Blood Pressure Monitor, KUBE/Kinetik Branded BPM1K Series 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.
Non-Invasive Blood Pressure Measurement System
The provided text is a 510(k) premarket notification letter from the FDA to Harvard-Medical-Devices Limited regarding their KUBE/Kinetik Branded BPM1K Series blood pressure monitor. While it confirms the device's substantial equivalence to a predicate device and outlines regulatory obligations, it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table and detailed study information based on the text provided. This document is an FDA approval letter, not a study report or a detailed summary of the testing performed.
§ 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).