K240860
- 510(k) number
- K240860
- Device name
- EchoGo Amyloidosis (1.0)
- Applicant
- Ultromics Limited GB
- Product code
- SDJ — Adjunctive Cardiac Amyloidosis Status Indicator
- Decision date
- 2024-11-15
- Date received
- 2024-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240860.pdf
Official FDA record: K240860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.