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FDA 510(k)

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

K-Number: K182868 · 2019-01-08

ApplicantCovidien, LLC
Decision Date2019-01-08
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2019-01-08 under approval number K182868. 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 Adult rSO2 Sensor?

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor is a medical device that received FDA 510(k) clearance on 2019-01-08. It is manufactured by Covidien, LLC. The 510(k) number is K182868.

When was INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor approved by the FDA?

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor received FDA 510(k) clearance on 2019-01-08, under approval number K182868.

What company makes INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor?

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor is manufactured by Covidien, LLC.

What is the FDA product code for INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor?

The FDA product code for INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor is MUD.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

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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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