Cleared Traditional

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

K211561 · Covidien, LLC · Neurology
Dec 2021
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K211561 is an FDA 510(k) clearance for the INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor), a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 5, 2021, 199 days after receiving the submission on May 20, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K211561 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2021
Decision Date December 05, 2021
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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