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FDA 510(k)

HeartBeam AIMIGo(TM) System

K-Number: K231424 · 2024-12-13

ApplicantHeartbeam, Inc.
Decision Date2024-12-13
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartBeam AIMIGo(TM) System is the device name listed in this FDA 510(k) record. The listed applicant is Heartbeam, Inc.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K231424. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartBeam AIMIGo(TM) System?

HeartBeam AIMIGo(TM) System is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Heartbeam, Inc.. The 510(k) number is K231424.

When did HeartBeam AIMIGo(TM) System receive FDA 510(k) clearance?

HeartBeam AIMIGo(TM) System received FDA 510(k) clearance on 2024-12-13, under 510(k) number K231424.

Who is the listed applicant for HeartBeam AIMIGo(TM) System?

The FDA 510(k) record lists Heartbeam, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartBeam AIMIGo(TM) System?

The FDA product code for HeartBeam AIMIGo(TM) System is MWJ.

Other records listing Heartbeam, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software System

Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd.K222017BiotresBiotricity

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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