Eutectic Electronics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Eutectic Electronics, Inc. makes
Eutectic Electronics, Inc. manufactures wearable heart-rate monitors, including the AccuTracker and an ultrcompact design, for continuous cardiac monitoring and fitness tracking applications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Accutracker Heart-Rate Monitor Ref K850867
510(k) 510(k)Ultracompact Ref K894968
510(k) 510(k)
Frequently asked questions
How many devices does Eutectic Electronics, Inc. have in the registry?
The registry currently lists 2 devices for Eutectic Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eutectic Electronics, Inc.'s devices?
Among its 2 most recently registered devices, Eutectic Electronics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Eutectic Electronics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eutectic Electronics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eutectic Electronics, Inc. in the registry?
The most recently registered devices listed for Eutectic Electronics, Inc. include ACCUTRACKER HEART-RATE MONITOR and ULTRACOMPACT.