K-number	K211640
Device name	Ponto 5 Mini
Applicant	Oticon Medical AB
Product code	LXB
Device class	Class II
Decision date	Aug 10, 2021
Decision	Substantially Equivalent
Regulation	874.3302

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Source

View the full FDA submission: accessdata.fda.gov

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Ponto 5 Mini

Everything you need for a 510(k) submission. Nothing you don't.