Irhythm Technologies Inc

FDA Filings

This page includes the latest FDA filings for Irhythm Technologies Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQIRTCDUNS 861237670
FDA Registration(s)
Registration Number3007208829
FEI Number3007208829
NameIRHYTHM TECHNOLOGIES, INC.
Owner & OperatoriRhythm Technologies, Inc.
Contact Address699 8th St Suite 600
San Francisco CA 94103 US
Official Correspondent
  • Rich Laguna
  • x-415-6325700-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address699 8th Street Suite 600
San Francisco, CA 94103 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3008363157
FEI Number3008363157
NameiRhythm Technologies, Inc. Orange County
Owner & OperatoriRhythm Technologies, Inc.
Contact Address699 8th St Suite 600
San Francisco CA 94103 US
Official Correspondent
  • Rich Laguna
  • x-415-6325700-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address11085 Knott Ave Ste B
Cypress, CA 90630 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
IRhythm Technologies, Inc.
Zio ECG Utilization Software (ZEUS) System2021-05-21
IRhythm Technologies, Inc.
Zio Monitor2021-05-21
IRHYTHM TECHNOLOGIES, INC.
ZIO SR Patch 2019-11-08
IRHYTHM TECHNOLOGIES, INC.
ZIO AT Patch 2019-11-08
IRHYTHM TECHNOLOGIES, INC.
ZIO XT Patch 2019-11-08
IRHYTHM TECHNOLOGIES, INC.
Zio ECG Utilization Service (ZEUS) System2019-09-04
IRhythm Technologies, Inc.
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System2019-08-23
IRhythm Technologies, Inc.
Zio AT ECG Monitoring System, ZEUS System2018-08-29
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Patch2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Gateway2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
ZEUS System2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Patch2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Gateway2017-09-01
IRHYTHM TECHNOLOGIES, INC.
ZEUS System2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Patch2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Gateway2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
ZEUS System2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Patch2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Gateway2017-09-01
IRHYTHM TECHNOLOGIES, INC.
ZEUS System2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Patch2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Gateway2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
ZEUS System2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Patch2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Gateway2017-09-01
IRHYTHM TECHNOLOGIES, INC.
ZEUS System2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Patch2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? AT Gateway2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
ZEUS System2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Patch2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio? AT Gateway2017-09-01
IRHYTHM TECHNOLOGIES, INC.
ZEUS System2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Razor2017-09-01
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Tape Remover Pad2017-09-01
IRHYTHM TECHNOLOGIES, INC.
Zio AT ECG Monitoring System2017-06-02
IRhythm Technologies, Inc.
ZIO SR ECG Monitoring Service2015-06-19
IRhythm Technologies, Inc.
ZEUS (ZIO ECG Utilization Service) System2014-11-21
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? XT Patch2012-12-26
iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]
Zio? XT Patch CE2012-12-26
IRHYTHM TECHNOLOGIES, INC.
Zio? XT Patch2012-12-26
IRHYTHM TECHNOLOGIES, INC.
Zio? XT Patch CE2012-12-26
IRHYTHM TECHNOLOGIES, INC.
ZIO PATCH2012-07-18
IRHYTHM TECHNOLOGIES, INC.
ZIO PATCH2012-02-06
IRHYTHM TECHNOLOGIES, INC.
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM2009-07-21
IRHYTHM TECHNOLOGIES, INC.
ZIO PATCH, MODEL Z1002009-05-08
IRHYTHM TECHNOLOGIES, INC.
ECARD AND CCARD2008-06-24

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