RhythmStar System— 510(k) K233584
Substantially EquivalentRhythMedix, LLC
FDA 510(k) clearance K233584 for RhythmStar System, Substantially Equivalent on 2024-07-08. Applicant: RhythMedix, LLC.
Clearance details
- Applicant
- RhythMedix, LLC
- Product code
- Code QYX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mt. Laurel, NJ, US
Adverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.