K-number	K223676
Device name	SomniCheck
Applicant	Brainmatterz, LLC
Product code	GWL
Device class	Class II
Decision date	Jun 1, 2023
Decision	Substantially Equivalent
Regulation	882.1835

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Source

View the full FDA submission: accessdata.fda.gov

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SomniCheck

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