FDA.reportPublic FDA data

IRHYTHM TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072088293007208829IRHYTHM TECHNOLOGIES, INC.1N2026-01-01699 8th Street Suite 600 San Francisco CA US 94103
30217690573021769057iRhythm Technologies, Inc.1N2026-01-016550 Katella Avenue Cypress CA US 90630

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
899721842897094K243650Zio® monitor (DFG0001)DSH2025-08-15
3030671842897094K243650Zio® monitor (DFG0001)DSH2025-08-15
3030671966288299K240177Zio AT® device (A100A1001)DSI2024-10-30
899721966288299K240177Zio AT® device (A100A1001)DSI2024-10-30
3030671718711317K240029Zio AT® device (A100A1001)QYX2024-10-21
899721718711317K240029Zio AT® device (A100A1001)QYX2024-10-21
899722039619059K222389ZEUS SystemDQK2023-02-15
899721225858955K213409ZEUS System (Zio Watch)DQK2022-07-19
899721620106200K202527Zio ECG Utilization Software (ZEUS) SystemDQK2021-05-21
899721591603834K202359Zio MonitorDSH2021-05-21
3030671591603834K202359Zio MonitorDSH2021-05-21
899721752964585K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemDQK2019-08-23
899721599972564K181502Zio AT ECG Monitoring System, ZEUS SystemDQK2018-08-29
899721132834170K163512Zio AT ECG Monitoring SystemQYX2017-06-02
3030671132834170K163512Zio AT ECG Monitoring SystemQYX2017-06-02
899722035250187K121319ZIO PATCHDSH2012-07-18
3030672035250187K121319ZIO PATCHDSH2012-07-18
3030671234929869
3030671983348304

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH62025-08-15
DQK52023-02-15
QYX42024-10-21
DSI22024-10-30

PMN#

GUDID#