K-number	K222247
Device name	Hailie Sensor NF0110
Applicant	Adherium (Nz), Ltd.
Product code	CAF
Device class	Class II
Decision date	Feb 8, 2023
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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Hailie Sensor NF0110

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