Critical Care Suite with Endotracheal Tube Positing AI algorithm— 510(k) K211161
Substantially EquivalentGe 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.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.