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 Computer, Diagnostic, Programmable
510(k) Number K190593
Device Name Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Applicant
Irhythm Technologies, Inc.
650 Townsend St., Suite 500
San Francisco,  CA  94103
Applicant Contact Gabrielle Logan
Correspondent
Irhythm Technologies, Inc.
650 Townsend St., Suite 500
San Francisco,  CA  94103
Correspondent Contact Gabrielle Logan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/07/2019
Decision Date 08/23/2019
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
-
-