K240013
- 510(k) number
- K240013
- Device name
- EchoGo Heart Failure (2.0)
- Applicant
- Ultromics Limited GB
- Product code
- QUO — Adjunctive Heart Failure Status Indicator
- Decision date
- 2024-09-23
- Date received
- 2024-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240013.pdf
Official FDA record: K240013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.