510(k) K200833
K200833 is an FDA 510(k) premarket notification submitted by VivaQuant, Inc. for the device "RX-1 Rhythm Express Remote Cardiac Monitoring System". The FDA issued a decision of Substantially Equivalent on September 2, 2020. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. VivaQuant, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2020
- Date Received
- March 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type