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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2019-01-08 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K182868.

When did INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor?

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 Adult rSO2 Sensor?

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

Related Clinical Trials

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NCT07760129Erector Spinae Oxygen Saturation and AKI After OPCABNOT_YET_RECRUITINGNCT07166341Accuracy Verification of the INVOS PM7100COMPLETED

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Related Devices (Code: MUD)

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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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