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EsC38and)s - accessdata fda

EsC38and)s - accessdata fda 2025

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The document is a 510(k) summary for the BIL-THERAPY Spot Type, a neonatal phototherapy unit developed by Atom Medical Corporation. It outlines the device's intended use for treating neonatal hyperbilirubinemia, its equivalence to the predicate device Respironics BiliTx, and compliance with relevant safety standards. The summary includes details about the device's design, technology, performance testing, and regulatory approval from the FDA.

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EsC38and)s - accessdata fda 2025

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