Novx Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Novx Systems, Inc. makes
Novx Systems, Inc. manufactures implantable medical device systems, including the IMDX Systems, which are designed for specific diagnostic or monitoring applications in cardiac or neurological settings. The company also provides related consumables such as the IMDX Analyzer, IMDXPrep reagent plates, calibration plates, and control plates to support device functionality and testing.
The company’s portfolio is classified under FDA’s Class II medical devices and is subject to 510(k) premarket notification requirements. These products are listed with the U.S. Food and Drug Administration, adhering to regulatory standards for safety and performance in their designated medical applications.
Catalogue
Imdx Systems Ref K063699
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novx Systems, Inc. have in the registry?
The registry currently lists 2 devices for Novx Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novx Systems, Inc.'s devices?
Among its 2 most recently registered devices, Novx Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Novx Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Novx Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novx Systems, Inc. in the registry?
The most recently registered devices listed for Novx Systems, Inc. include IMDX SYSTEMS and IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL.