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510(k) K243650

Zio® monitor (DFG0001) by iRhythm Technologies, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
November 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by iRhythm Technologies, Inc.

  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K240029 — Zio AT® device (A100A1001) (October 21, 2024)
  • K222389 — ZEUS System (February 15, 2023)
  • K213409 — ZEUS System (Zio Watch) (July 19, 2022)
  • K202527 — Zio ECG Utilization Software (ZEUS) System (May 21, 2021)
  • K202359 — Zio Monitor (May 21, 2021)
  • K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (August 23, 2019)
  • K181502 — Zio AT ECG Monitoring System, ZEUS System (August 29, 2018)
  • K163512 — Zio AT ECG Monitoring System (June 2, 2017)
  • K143513 — ZIO SR ECG Monitoring Service (June 19, 2015)

Other clearances for product code DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)
  • K223382 — AeviceMD (July 7, 2023)