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Global Headquarters (I emb Ia - accessdata fda

Global Headquarters (I emb Ia - accessdata fda 2025

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The document is a 510(k) summary for the Embletta MPR Sleep Data Recording System, submitted by Embla Systems. It provides detailed information about the device, including its identification, intended use, and comparison to predicate devices. The Embletta MPR is designed to record multiple physiological parameters during sleep to assist in diagnosing sleep disorders. It is intended for use under the supervision of healthcare professionals and can be applied by laypersons. The document also outlines testing and performance data, concluding that the device is substantially equivalent to existing devices on the market.

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