K-number	K240555
Device name	Tyto Insights for Crackles Detection
Applicant	Tyto Care , Ltd.
Product code	PHZ
Device class	Class II
Decision date	Jul 2, 2024
Decision	Substantially Equivalent
Regulation	868.1900

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Source

View the full FDA submission: accessdata.fda.gov

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Tyto Insights for Crackles Detection

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