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510(k) K183704

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2019
Date Received
December 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Vivaquant, Inc.

  • K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (July 11, 2025)
  • K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System (September 2, 2020)

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