Heartbeam, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Heartbeam, Inc. makes
Heartbeam, Inc. manufactures the HeartBeam AIMIGo™ System, a medical device designed for electrocardiogram (ECG) monitoring, including a version integrated with 12-lead ECG synthesis software. The system is intended for use in cardiac monitoring and diagnostic applications.
The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
HeartBeam AIMIGo(TM) System Ref K231424
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 069464049
Frequently asked questions
How many devices does Heartbeam, Inc. have in the registry?
The registry currently lists 3 devices for Heartbeam, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartbeam, Inc.'s devices?
Among its 3 most recently registered devices, Heartbeam, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Heartbeam, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Heartbeam, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heartbeam, Inc. in the registry?
The most recently registered devices listed for Heartbeam, Inc. include HeartBeam ECG System 5002A, HeartBeam AIMIGo(TM) System and HeartBeam AIMIGo with 12-L ECG Synthesis Software System.