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The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.

The Citizen CH-491, CH-481 and CH-471 digital arm sphygmomanometers are noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's upper arm. The units are contained in a hard plastic housing that contains a user interface panel, microprocessor and air pump and is connected by tubing to an adjustable arm cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD"). The user interface panel for the CH-481 has an additional switch to control the memory function, while the user interface panel for the CH-491 has additional switches to control the clock and memory functions.

The device measures blood pressure through the use of an automatically-inflating arm cuff. The cuff automatically deflates during blood pressure measurement. Model CH-471 has a memory function that displays the last blood pressure readout when the system is turned on. Model CH-481 has a memory function that allows the user to retain seven (7) prior blood pressure measurements. Model CH-491 has a memory function that allows the user to retain thirty (30) prior blood pressure measurements and also includes an LCD display that shows blood pressure measurement in a graph format.

The provided text is a 510(k) summary for the Citizen Watch Company's CH-491, CH-481, and CH-471 Blood Pressure Meters. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain information about acceptance criteria or specific study data to prove the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent detailed questions about a study. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed performance study against predefined acceptance criteria.

The document indicates that Citizen "determined that these changes have no influence on the correct measuring and the accuracy of systolic and diastolic blood pressure" compared to the predicate device (CH-401). However, it does not provide the underlying data or studies to support this determination.

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