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510(k) K231424

HeartBeam AIMIGo(TM) System by Heartbeam, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
May 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Heartbeam, Inc.

  • K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (December 8, 2025)

Other clearances for product code MWJ

  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K222017 — Biotres (July 28, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)
  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)