iRhythm Technologies, Inc.

FDA Device Registration & Listing · Cypress, CA, US · Registration 3021769057

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
3021769057
FEI Number
3021769057
Entity Name
iRhythm Technologies, Inc.
City/State/Country
Cypress, CA, US
Establishment Address
6550 Katella Avenue, Cypress, CA 90630, US
Establishment Type(s)
Manufacture Medical Device
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
K121319
PMA Number
N/A

All Registered Proprietary Names

Zio AT device Zio® AT Patch ZEUS System Zio® AT Gateway Razor Zio monitor device Zio Monitor Zio AT device Zio® XT Patch Zio® XT Patch CE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-01-21
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2025-01-21
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-01-21
QYX Outpatient Cardiac Telemetry Cardiovascular Class 2 870.1025 2025-01-21
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
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2017-09-01
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2026-01-08
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2021-05-27
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-01-21
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2025-01-21
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2025-01-21
QYX Outpatient Cardiac Telemetry Cardiovascular Class 2 870.1025 2025-01-21
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2012-12-26

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
3007208829 IRHYTHM TECHNOLOGIES, INC. San Francisco, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04
K033410 Remote Diagnostic Technologies , Ltd. TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 2004-03-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2025 Philips North America 2
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05 General Electric Medical Systems Information Technology 2
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011 Philips Medical Systems North America Co. Phillips 2
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025 Philips North America 2
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021769057. Last updated year: 2026. Please use registration number 3021769057 when referencing this establishment in official correspondence.
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