(109 days)
The model MB-300 Series Upperarm Digital Blood Pressure Monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in addrio, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Upperarm Digital Blood Pressure Monitor (Upperarm Digital Sphygmomanometer), Model MB-300 Series
The provided text is a letter from the FDA regarding a 510(k) premarket notification for an Upperarm Digital Blood Pressure Monitor. It does not contain the acceptance criteria, reported device performance, or details of a study (like sample size, ground truth, expert information, or specific study types like MRMC or standalone) to prove the device meets said criteria.
Therefore, I cannot fulfill your request for this information from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the FDA's regulatory decision, but doesn't detail the performance study data itself.
§ 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).