K-number	K240614
Device name	Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Applicant	Oticon Medical AB
Product code	PFO
Device class	Class II
Decision date	Jul 10, 2024
Decision	Substantially Equivalent
Regulation	874.3340

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Source

View the full FDA submission: accessdata.fda.gov

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Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

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