(30 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Not Found
The provided text is a 510(k) clearance letter for the Omron Automatic Blood Pressure Monitor, Model HEM-711AC. This type of document declares a device to be "substantially equivalent" to a predicate device, meaning it's as safe and effective as a device already legally marketed. It does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) clearance process generally involves demonstrating substantial equivalence through various means, which can include performance data, but the specific details of such studies and acceptance criteria are typically found in the submission itself, not the clearance letter.
Therefore, I cannot provide the requested information from the given text. The document only states that the device is cleared for marketing based on substantial equivalence.
§ 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).