Home / 510(k) Clearances / K210179

510(k) K210179

QOCA Portable ECG Monitoring Device by Quanta Computer, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2022
Date Received
January 22, 2021
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 Quanta Computer, Inc.

  • K231855 — QOCA® image Smart RT Contouring System (February 13, 2024)
  • K221868 — QOCA image Smart CXR Image Processing System (January 27, 2023)
  • K083079 — QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 (March 5, 2009)
  • K083078 — QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 (November 26, 2008)

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)