Heartscape Technologies, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Heartscape Technologies, Ltd. makes
Heartscape Technologies, Ltd. manufactures the PRIME ECG System, a diagnostic device featuring an enhanced algorithm for electrocardiogram analysis to improve cardiac assessment accuracy.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heartscape Technologies, Ltd. have in the registry?
The registry currently lists 1 device for Heartscape Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartscape Technologies, Ltd.'s devices?
Among its 1 most recently registered device, Heartscape Technologies, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Heartscape Technologies, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Heartscape Technologies, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heartscape Technologies, Ltd. in the registry?
The most recently registered devices listed for Heartscape Technologies, Ltd. include PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM).