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FDA 510(k)

Critical Care Suite with Endotracheal Tube Positing AI algorithm

K-Number: K211161 · 2021-10-29

ApplicantGe Medical Systems, LLC
Decision Date2021-10-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Critical Care Suite with Endotracheal Tube Positing AI algorithm is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-10-29 under approval number K211161. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Critical Care Suite with Endotracheal Tube Positing AI algorithm?

Critical Care Suite with Endotracheal Tube Positing AI algorithm is a medical device that received FDA 510(k) clearance on 2021-10-29. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K211161.

When was Critical Care Suite with Endotracheal Tube Positing AI algorithm approved by the FDA?

Critical Care Suite with Endotracheal Tube Positing AI algorithm received FDA 510(k) clearance on 2021-10-29, under approval number K211161.

What company makes Critical Care Suite with Endotracheal Tube Positing AI algorithm?

Critical Care Suite with Endotracheal Tube Positing AI algorithm is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for Critical Care Suite with Endotracheal Tube Positing AI algorithm?

The FDA product code for Critical Care Suite with Endotracheal Tube Positing AI algorithm is QIH.

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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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