Critical Care Suite with Endotracheal Tube Positing AI algorithm— 510(k) K211161

Name: FDA 510(k) clearance K211161
Creator: U.S. Food and Drug Administration
Published: 2021-10-29

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K211161 for Critical Care Suite with Endotracheal Tube Positing AI algorithm, Substantially Equivalent on 2021-10-29. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-04-19
Decision date: 2021-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.