(249 days)
The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate. This device is for use by adult population ( 18 years and older.) This is a non-invasive electronic sphygmomanometer.
Automatic Blood Pressure Recording Device
The provided document is a 510(k) clearance letter from the FDA for a blood pressure device. It does not contain acceptance criteria, detailed study information, or performance metrics in the format requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not specify the studies performed to demonstrate this equivalence, nor does it provide performance data.
Therefore, I cannot extract the information required to populate the table and answer the specific questions about acceptance criteria and study details. The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed presentation of performance 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).