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510(k) K233521

QT ECG (QTERD100) by QT Medical, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2023
Date Received
November 1, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by QT Medical, Inc.

  • K220795 — QT ECG (September 26, 2022)
  • K200722 — PCA-C1 series Patient Cable (June 3, 2021)
  • K180157 — QT ECG (May 4, 2018)

Other clearances for product code DXH

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  • K243981 — Hexoskin Medical System (7100-00016) (November 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (June 17, 2025)
  • K222842 — V-Patch Cardiac Monitor (October 20, 2022)
  • K220795 — QT ECG (September 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)
  • K211668 — KardiaMobile Card (November 30, 2021)