FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K Number: K241179
·
Decision Jul 11, 2025
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
3
Review Days
438
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Basic Information
- Device Name
- Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
- K Number
- K241179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VivaQuant, Inc.
- Date Received
- April 29, 2024
- Decision Date
- July 11, 2025
- 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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