K233584
- 510(k) number
- K233584
- Device name
- RhythmStar System
- Applicant
- RhythMedix, LLC NJ · US
- Product code
- QYX — Outpatient Cardiac Telemetry
- Decision date
- 2024-07-08
- Date received
- 2023-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233584.pdf
Official FDA record: K233584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.