Cat b'3Ful' 2025

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The document is a 510(k) summary for the iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock, submitted by Andon Health Co., Ltd. It outlines the device's classification as a non-invasive blood pressure measurement system, its intended use for measuring diastolic and systolic blood pressures and pulse rate in adults, and its operational principles based on oscillometric technology. The summary compares the device to a predicate device (KD-930), demonstrating substantial equivalence in safety and effectiveness, while noting minor differences in design and functionality.

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Cat b'3Ful' 2025

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