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FDA 510(k)

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

K-Number: K211561 · 2021-12-05

ApplicantCovidien, LLC
Decision Date2021-12-05
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2021-12-05 under 510(k) number K211561. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) is a medical device that received FDA 510(k) clearance on 2021-12-05. The listed applicant is Covidien, LLC. The 510(k) number is K211561.

When did INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) receive FDA 510(k) clearance?

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) received FDA 510(k) clearance on 2021-12-05, under 510(k) number K211561.

Who is the listed applicant for INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)?

The FDA product code for INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) is MUD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07760129Erector Spinae Oxygen Saturation and AKI After OPCABNOT_YET_RECRUITINGNCT07739823Validation of a Wireless Wearable Vital Signs Monitor in Pediatric PatientNOT_YET_RECRUITINGNCT07166341Accuracy Verification of the INVOS PM7100COMPLETEDNCT07615738SpO2 Infant and Pediatric StudyNOT_YET_RECRUITINGNCT06050720Sleep Apnoea Breathing Record Exploratory Study (SABRES)COMPLETEDNCT06232876Continuous Versus Intermittent Ward MonitoringNOT_YET_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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