K-number	K231546
Device name	Somfit
Applicant	Compumedics Limited
Product code	MNR
Device class	Class II
Decision date	Nov 30, 2023
Decision	Substantially Equivalent
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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Somfit

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