Class Class II

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

K250258 2025-12-08 Traditional
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Description

HeartBeam AIMIGo with 12-L ECG Synthesis Software System by Heartbeam, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250258
Clearance Date2025-12-08
Clearance TypeTraditional
Product CodeDXH
Regulation Number870.2920

Categories

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