FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RhythmStar System
K Number: K233584
·
Decision Jul 8, 2024
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
3
Review Days
244
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Basic Information
- Device Name
- RhythmStar System
- K Number
- K233584
- 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
- November 7, 2023
- Decision Date
- July 8, 2024
- 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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