(88 days)
Model CH-101 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Not Found
The provided text is a 510(k) Pre-market Notification letter from the FDA to Citizen Systems Japan Co., LTD, regarding their Citizens Blood Pressure Meter, Model CH-101. It details the substantial equivalence determination and regulatory requirements. However, it does not contain the acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria.
§ 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).