K-number	K210623
Device name	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
Applicant	Sebia
Product code	DFH
Device class	Class II
Decision date	Nov 18, 2022
Decision	Substantially Equivalent
Regulation	866.5550

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Source

View the full FDA submission: accessdata.fda.gov

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FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

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