Name: Predicase
Price: 199 USD

K-number	K211561
Device name	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
Applicant	Covidien, LLC
Product code	MUD
Device class	Class II
Decision date	Dec 5, 2021
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 Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

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