K250793
- 510(k) number
- K250793
- Device name
- RhythmStar System (SL)
- Applicant
- RhythMedix, LLC NJ · US
- Product code
- QYX — Outpatient Cardiac Telemetry
- Decision date
- 2026-04-21
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K250793.pdf
Official FDA record: K250793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.