K230145

Substantially Equivalent

ONE-CUF

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: DXQ
Advisory panel: Cardiovascular
Date received: 2023-01-18
Decision date: 2023-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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