Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K200833
Device Name RX-1 Rhythm Express Remote Cardiac Monitoring System
Applicant
Vivaquant, Inc.
4339 Nancy Place, Suite 100
St. Paul,  MN  55126
Applicant Contact Brian Brockway
Correspondent
Borderless Compliance, LLC
7118 Teakwood Cir
Maple Grove,  MN  55369
Correspondent Contact Brodie Pedersen
Regulation Number870.2800
Classification Product Code
MLO  
Subsequent Product Code
DSI  
Date Received03/30/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-