IRHYTHM TECHNOLOGIES, INC.

FDA Device Registration & Listing · San Francisco, CA, US · Registration 3007208829

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007208829
FEI Number
3007208829
Entity Name
IRHYTHM TECHNOLOGIES, INC.
City/State/Country
San Francisco, CA, US
Establishment Address
699 8th Street, Suite 600, San Francisco, CA 94103, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
iRhythm Technologies, Inc. (Owner Number: 10026250)
Owner / Operator Contact Address
699 8th St, Suite 600, San Francisco, CA 94103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181502
PMA Number
N/A

All Registered Proprietary Names

ZEUS Athena System Zio® XT Patch Zio® XT Patch CE Zio ECG Utilization Software (ZEUS) System Zio monitor device Zio ECG Utilization Service (ZEUS) System Zio® AT Patch ZEUS System Zio® AT Gateway

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-07-25
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2022-07-25
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2012-12-26
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2021-05-27
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2021-05-27
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-05-27
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2026-01-08
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2019-09-04
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2017-09-01
QYX Outpatient Cardiac Telemetry Cardiovascular Class 2 870.1025 2017-09-01
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2017-09-01
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2017-09-01
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-09-01
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-11-15

Official Correspondent

Chanda Owens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iRhythm Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021769057 iRhythm Technologies, Inc. Cypress, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935043 Siemens Medical Electronics SIEMENS CLINICAL WORK STATION 1995-04-07
K170948 Acutus Medical, Inc. AcQMap High Resolution Imaging and Mapping System 2017-10-16
K242016 ABBOTT MEDICAL EnSite™ X EP System 2024-08-09
K172182 St. Jude Medical (Now Part of the Abbott Medical) QUANTIEN Measurement System 2017-08-18
K252013 ABBOTT MEDICAL EnSite™ X EP System 2025-09-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2016 Biosense Webster, Inc. 2
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007208829. Last updated year: 2026. Please use registration number 3007208829 when referencing this establishment in official correspondence.
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