(9 days)
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic & systolic) and pulse rate in adult patients with arm circumferences from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
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This document is an FDA 510(k) clearance letter for A&D Engineering Inc.'s Digital Blood Pressure Monitors. Unfortunately, the provided text does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to "indications for use" and "general controls provisions of the Act," but does not elaborate on the specific performance metrics or studies used to validate the device's accuracy or effectiveness.
Therefore, I cannot provide the requested information from the given input. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which typically includes the performance data and study details.
§ 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).