K-number	K182868
Device name	INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Applicant	Covidien, LLC
Product code	MUD
Device class	Class II
Decision date	Jan 8, 2019
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

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