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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.

OMRON Automatic Blood Pressure Monitor, Model: HEM-741CRELN (OMRON Internal Model Name: HEM-7041-W)

This is a 510(k) premarket notification for the Omron Automatic Blood Pressure Monitor, Model HEM-741CRELN. This document primarily focuses on FDA clearance for market entry and does not contain the detailed study information requested. Therefore, I cannot provide the specific details about acceptance criteria and study results as this information is not present in the provided text.

The document indicates that the device is a Noninvasive Blood Pressure Measurement System regulated under 21 CFR 870.1130 (Class II) and has the product code DXN. It also states the Indication for Use is "measuring blood pressure and pulse rate in adult patient population" and "detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings."

To answer your questions, I would need to have access to the actual premarket notification (510(k) submission) itself, which would include the study data demonstrating substantial equivalence to a predicate device. The provided text is only the FDA's clearance letter.

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