ONE-CUF— 510(k) K230145
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K230145 for ONE-CUF, Substantially Equivalent on 2023-03-14. Applicant: Ge Medical Systems Information Technologies, Inc..
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code DXQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.