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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel . . . : ー The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .

H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888HA. Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888HA). It does not contain a study report or detailed information about the acceptance criteria and performance of the device beyond its classification and indication for use. Therefore, I cannot provide the requested information about the study that proves the device meets specific acceptance criteria based on this document.

The document indicates:

• Device Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (Trade Name: HL888HA)
• Regulation Number: 21 CFR 870.1130 (Non-invasive Blood Pressure Measurement System)
• Regulatory Class: Class II
• Indications For Use: Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. Intended for adult patients whose arm circumference is between 24-32 cm.

To answer your request, a separate study report or a more detailed submission document (which is not provided) would be needed.

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