FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RX-1 Rhythm Express Remote Cardiac Monitoring System
K Number: K200833
·
Decision Sep 2, 2020
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
3
Review Days
156
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Basic Information
- Device Name
- RX-1 Rhythm Express Remote Cardiac Monitoring System
- K Number
- K200833
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VivaQuant, Inc.
- Date Received
- March 30, 2020
- Decision Date
- September 2, 2020
- Product Code
- MLO
- 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 |
|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | FDA class 2 | Cardiovascular |
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