Tidepool Project
United Statesfrom the FDA registration address FDA FEI 3012128418
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Tidepool Project makes
The Tidepool Project develops the Tidepool Loop, an integrated diabetes management system combining continuous glucose monitoring (CGM) and automated insulin delivery (AID) via smartphone integration to assist individuals with insulin-dependent diabetes in managing blood glucose levels.
The Tidepool Loop is classified as a Class II medical device in the US and has been authorised through the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Tidepool Loop Ref K203689
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3012128418
- Address
- 3340 Hillview Ave., Palo Alto, CA, 94304
Frequently asked questions
How many devices does Tidepool Project have in the registry?
The registry currently lists 1 device for Tidepool Project. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tidepool Project's devices?
Among its 1 most recently registered device, Tidepool Project has devices listed in FDA 510(k) (1 device).
What risk classes do Tidepool Project's devices fall under?
Among its 1 most recently registered device, the classes recorded for Tidepool Project's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tidepool Project in the registry?
The most recently registered devices listed for Tidepool Project include Tidepool Loop.