K-number	K220622
Device name	Hailie Sensor NF0106
Applicant	Adherium (Nz), Ltd.
Product code	CAF
Device class	Class II
Decision date	Jul 15, 2022
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 NF0106

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