K-number	K223163
Device name	Sleepiz One+
Applicant	Sleepiz AG
Product code	DRT
Device class	Class II
Decision date	Aug 18, 2023
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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Sleepiz One+

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