DeviceClearance

HeartBeam AIMIGo with 12-L ECG Synthesis Software System— 510(k) K250258

Substantially Equivalent

Heartbeam, Inc.

FDA 510(k) clearance K250258 for HeartBeam AIMIGo with 12-L ECG Synthesis Software System, Substantially Equivalent on 2025-12-08. Applicant: Heartbeam, Inc..

Clearance details

Applicant
Heartbeam, Inc.
Product code
Code DXH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.