Medical Device Manufacturer · US , Emeryville , CA

Eko Health, Inc.

3 submissions · 3 cleared · Since 2024
3
Total
3
Cleared
0
Denied

Eko Health, Inc. — FDA 510(k) Submissions

Eko Health, Inc. has submitted 3 FDA 510(k) premarket notifications since 2024, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stethoscope, Electronic, Reduced Ejection Fraction Machine Learning-based Notification Software . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
Filters
All3 Cardiovascular 3