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 a medical device manufactured by Heartbeam, Inc.. It received FDA 510(k) clearance on 2024-12-13 under approval 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. It is manufactured by Heartbeam, Inc.. The 510(k) number is K231424.
When was HeartBeam AIMIGo(TM) System approved by the FDA?
HeartBeam AIMIGo(TM) System received FDA 510(k) clearance on 2024-12-13, under approval number K231424.
What company makes HeartBeam AIMIGo(TM) System?
HeartBeam AIMIGo(TM) System is manufactured by Heartbeam, Inc..
What is the FDA product code for HeartBeam AIMIGo(TM) System?
The FDA product code for HeartBeam AIMIGo(TM) System is MWJ.
Other Devices by Heartbeam, Inc.
Related Devices (Code: MWJ)
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.