Medical Device Manufacturer · US , San Francisco , CA

iRhythm Technologies, Inc.

17 submissions · 17 cleared · Since 2008
17
Total
17
Cleared
0
Denied

iRhythm Technologies, Inc. — FDA 510(k) Submissions

iRhythm Technologies, Inc. has submitted 17 FDA 510(k) premarket notifications since 2008, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable, Recorder, Magnetic Tape, Medical, Outpatient Cardiac Telemetry, Transmitters And Receivers, Electrocardiograph, Telephone, Detector And Alarm, Arrhythmia . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Zio? monitor (DFG0001)
K243650 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Aug 2025 262d
Zio AT? device (A100A1001)
K240177 · DSI Detector And Alarm,... · Cardiovascular
Oct 2024 281d
Zio AT? device (A100A1001)
K240029 · QYX Outpatient Cardiac Telemetry · Cardiovascular
Oct 2024 291d
ZEUS System
K222389 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2023 191d
ZEUS System (Zio Watch)
K213409 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2022 273d
Zio Monitor
K202359 · DSH Recorder, Magnetic Tape,... · Cardiovascular
May 2021 275d
Zio ECG Utilization Software (ZEUS) System
K202527 · DQK Computer, Diagnostic,... · Cardiovascular
May 2021 262d
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
K190593 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2019 169d
Zio AT ECG Monitoring System, ZEUS System
K181502 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2018 83d
Zio AT ECG Monitoring System
K163512 · QYX Outpatient Cardiac Telemetry · Cardiovascular
Jun 2017 169d
ZIO SR ECG Monitoring Service
K143513 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Jun 2015 190d
ZEUS (ZIO ECG Utilization Service) System
K142681 · DQK Computer, Diagnostic,... · Cardiovascular
Nov 2014 63d
ZIO PATCH
K121319 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Jul 2012 77d
ZIO PATCH
K113862 · DSH Recorder, Magnetic Tape,... · Cardiovascular
Feb 2012 38d
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2009 98d
ZIO PATCH, MODEL Z100
K090363 · DSH Recorder, Magnetic Tape,... · Cardiovascular
May 2009 84d
ECARD AND CCARD
K081471 · DXH Transmitters And... · Cardiovascular
Jun 2008 28d
Filters
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