(90 days)
The DynaPulse 500G is indicated for trained medical professionals to operate on partient at clinical settings to collect and measure blood pressure, pulser and pressure waveform information. In addition, the Dyllar uise 2000 is marcated to purchase week on the device does not send any administrate this device upon present and experience are required to check and interpret the information delivered.
DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor
This document is a 510(k) clearance letter from the FDA for the DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor. It does not contain the specific information requested about acceptance criteria, study details, or ground truth establishment. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from the provided text.
§ 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).