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510(k) K200833

RX-1 Rhythm Express Remote Cardiac Monitoring System by Vivaquant, Inc. — Product Code MLO

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

Other clearances by Vivaquant, Inc.

  • K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (July 11, 2025)
  • K183704 — RX-1 Rhythm Express Remote Cardiac Monitoring System (February 16, 2019)

Other clearances for product code MLO

  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K240794 — Frontier X Plus (November 8, 2024)
  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)