K-number	K193626
Device name	Masimo Rad-97 Pulse CO-Oximeter and Accessories
Applicant	Masimo Corporation
Product code	MWI
Device class	Class II
Decision date	Aug 10, 2020
Decision	Substantially Equivalent
Regulation	870.2300

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View the full FDA submission: accessdata.fda.gov

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Masimo Rad-97 Pulse CO-Oximeter and Accessories

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