(366 days)
The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation
Automatic Inflation Wrist Digital Blood Pressure Monitors
This document is a 510(k) clearance letter for the Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor, issued by the FDA in 1999. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device from the provided text.
The document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices and outlining general regulatory requirements.
§ 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).