K254066
- 510(k) number
- K254066
- Device name
- Etiometry Platform
- Applicant
- Etiometry, Inc. MA · US
- Product code
- PPW — Adjunctive Cardiovascular Status Indicator
- Decision date
- 2026-04-03
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K254066.pdf
Official FDA record: K254066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.