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510(k) K191406

KardiaMobile, KardiaStation by AliveCor, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
May 28, 2019
Clearance Type
Traditional
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 AliveCor, Inc.

  • K252589 — Corvair Monza (January 9, 2026)
  • K231010 — Corvair (June 7, 2024)
  • K232035 — Impala (June 7, 2024)
  • K220350 — KardiaMobile 6L (May 25, 2022)
  • K212662 — AliveCor QT Service (April 26, 2022)
  • K211668 — KardiaMobile Card (November 30, 2021)
  • K210753 — KardiaMobile 6L (June 30, 2021)
  • K201985 — KardiaAI (November 12, 2020)
  • K183319 — Triangle System (May 10, 2019)
  • K182396 — KardiaMobile, KardiaStation (April 12, 2019)

Other clearances for product code DXH

  • K250233 — PreemptiveAI Clinical SDK (February 13, 2026)
  • K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (December 8, 2025)
  • K243438 — MEMO Patch M (MPT-E08R-UNC01) (December 5, 2025)
  • K243981 — Hexoskin Medical System (7100-00016) (November 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (June 17, 2025)
  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • 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)