Amira Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Amira Medical, Inc. makes
Amira Medical, Inc. manufactures the Atlast Blood Glucose Monitoring System, a device for continuous or intermittent glucose level measurement, along with the Atlast Glucose Control Solution for calibration and testing. The company also provides Atlast Data Management Software (DMS) for tracking and analyzing glucose data, supporting diabetes management.
The Atlast Blood Glucose Monitoring System is authorised as a Class II device in the US under the FDA’s 510(k) pathway, while the Atlast Glucose Control Solution and Data Management Software fall under Class I regulatory classification. These products are listed in the FDA’s 510(k) database. The company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Atlast Glucose Control Solution Ref K991075
Regimes: 510(k) Registry: 510(k)Atlast Data Management Software (Dms) Ref K010605
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amira Medical, Inc. have in the registry?
The registry currently lists 3 devices for Amira Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amira Medical, Inc.'s devices?
Among its 3 most recently registered devices, Amira Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Amira Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Amira Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amira Medical, Inc. in the registry?
The most recently registered devices listed for Amira Medical, Inc. include AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM, ATLAST GLUCOSE CONTROL SOLUTION and ATLAST DATA MANAGEMENT SOFTWARE (DMS).