Dextra Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dextra Medical, Inc. makes
Dextra Medical, Inc. manufactures computer-based systems for cardiac analysis, including the D100 and D200 models, which perform diagnostic evaluations of electrocardiogram (ECG) data.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
D100 Computer Cardiac Analysis System Ref K863231
Regimes: 510(k) Registry: 510(k)D200 Advanced Computer Cardiac Analysis System Ref K863230
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dextra Medical, Inc. have in the registry?
The registry currently lists 2 devices for Dextra Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dextra Medical, Inc.'s devices?
Among its 2 most recently registered devices, Dextra Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dextra Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dextra Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dextra Medical, Inc. in the registry?
The most recently registered devices listed for Dextra Medical, Inc. include D100 COMPUTER CARDIAC ANALYSIS SYSTEM and D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM.