FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RhythmStar System (SL)
K Number: K250793
·
Decision Apr 21, 2026
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
3
Review Days
403
Basic Information
- Device Name
- RhythmStar System (SL)
- K Number
- K250793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RhythMedix, LLC
- Date Received
- March 14, 2025
- Decision Date
- April 21, 2026
- Product Code
- QYX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | FDA class 2 | Cardiovascular |
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