Diva Medical Systems, Inc.
Country not established
- Devices
- 1
What Diva Medical Systems, Inc. makes
Diva Medical Systems, Inc. manufactures the ROMEO™ Model 1000, a medical device designed for use in specific diagnostic or therapeutic procedures. This product is intended for applications requiring precise imaging or intervention within the vascular system, such as coronary angiography or interventional cardiology.
The ROMEO™ Model 1000 is classified as a Class II device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Romeo(Tm) Model 1000 Ref K872889
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diva Medical Systems, Inc. have in the registry?
The registry currently lists 1 device for Diva Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diva Medical Systems, Inc.'s devices?
Among its 1 most recently registered device, Diva Medical Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Diva Medical Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Diva Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diva Medical Systems, Inc. in the registry?
The most recently registered devices listed for Diva Medical Systems, Inc. include ROMEO(TM) MODEL 1000.