Calibra Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Calibra Medical, Inc. makes
Calibra Medical, Inc. manufactures the Finesse Personal Insulin Delivery Patch, a wearable device designed for continuous subcutaneous insulin infusion in diabetes management. The patch integrates a reservoir, pump mechanism, and infusion set to deliver precise insulin doses automatically or on demand.
The company’s insulin delivery patches are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Finesse Personal Insulin Delivery Patch Ref K111924
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Calibra Medical, Inc. have in the registry?
The registry currently lists 3 devices for Calibra Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calibra Medical, Inc.'s devices?
Among its 3 most recently registered devices, Calibra Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Calibra Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Calibra Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calibra Medical, Inc. in the registry?
The most recently registered devices listed for Calibra Medical, Inc. include FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000, FINESSE PERSONAL INSULIN DELIVERY PATCH and FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000.