K261569
- 510(k) number
- K261569
- Device name
- UbiqVue 2AYe Cardiac System (UX2253)
- Applicant
- Lifesignals, Inc. CA · US
- Product code
- DRG — Transmitters And Receivers, Physiological Signal, Ra
- Decision date
- 2026-07-09
- Date received
- 2026-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K261569.pdf
Official FDA record: K261569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.