FDA 510(k) Applications Submitted by iRhythm Technologies, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190593 |
03/07/2019 |
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System |
iRhythm Technologies, Inc. |
| K202527 |
09/01/2020 |
Zio ECG Utilization Software (ZEUS) System |
iRhythm Technologies, Inc. |
| K091075 |
04/14/2009 |
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM |
IRHYTHM TECHNOLOGIES, INC. |
| K121319 |
05/02/2012 |
ZIO PATCH |
IRHYTHM TECHNOLOGIES, INC. |
| K113862 |
12/30/2011 |
ZIO PATCH |
IRHYTHM TECHNOLOGIES, INC. |
| K181502 |
06/07/2018 |
Zio AT ECG Monitoring System, ZEUS System |
iRhythm Technologies, Inc. |
| K202359 |
08/19/2020 |
Zio Monitor |
iRhythm Technologies, Inc. |
| K142681 |
09/19/2014 |
ZEUS (ZIO ECG Utilization Service) System |
iRhythm Technologies, Inc. |
| K143513 |
12/11/2014 |
ZIO SR ECG Monitoring Service |
iRhythm Technologies, Inc. |
| K163512 |
12/15/2016 |
Zio AT ECG Monitoring System |
IRHYTHM TECHNOLOGIES, INC. |
| K240177 |
01/23/2024 |
Zio AT« device (A100A1001) |
iRhythm Technologies, Inc. |
| K240029 |
01/04/2024 |
Zio AT« device (A100A1001) |
iRhythm Technologies, Inc. |
| K222389 |
08/08/2022 |
ZEUS System |
iRhythm Technologies, Inc. |
| K213409 |
10/19/2021 |
ZEUS System (Zio Watch) |
iRhythm Technologies, Inc. |
| K090363 |
02/13/2009 |
ZIO PATCH, MODEL Z100 |
IRHYTHM TECHNOLOGIES, INC. |
| K081471 |
05/27/2008 |
ECARD AND CCARD |
IRHYTHM TECHNOLOGIES, INC. |
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