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510(k) K250258

HeartBeam AIMIGo with 12-L ECG Synthesis Software System by Heartbeam, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2025
Date Received
January 28, 2025
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 Heartbeam, Inc.

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)

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