K241479
- 510(k) number
- K241479
- Device name
- Etiometry Platform (DAV 5.4 RAE 9.2)
- Applicant
- Etiometry, Inc. MA · US
- Product code
- PPW — Adjunctive Cardiovascular Status Indicator
- Decision date
- 2025-02-12
- Date received
- 2024-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241479.pdf
Official FDA record: K241479
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.