K-number	K211807
Device name	Sapphire NC 24
Applicant	OrbusNeich Medical (Shenzhen) Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Oct 14, 2021
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Sapphire NC 24

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