Home / 510(k) Clearances / K172862

510(k) K172862

Portable ECG Monitor (ECG3) by Andon Health Co, Ltd. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2018
Date Received
September 20, 2017
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 Andon Health Co, Ltd.

  • K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wir (August 4, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic E (April 22, 2024)
  • K222869 — Arm Blood Pressure Monitor (February 15, 2023)
  • K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (December 21, 2022)
  • K212598 — iHealth infrared Ear thermometer PT5 (January 28, 2022)
  • K210768 — Wrist Blood Pressure Monitor, Blood Pressure Monitor (July 30, 2021)
  • K210770 — Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (July 29, 2021)
  • K202753 — iHealth Wireless No-Touch Forehead Thermometer (March 8, 2021)
  • K202791 — iHealth Clinical Digital Thermometer (January 5, 2021)

Other clearances for product code DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 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)