Florence Medical, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
What Florence Medical, Ltd. makes
Florence Medical, Ltd. manufactures intravascular pressure measurement devices, including the SMARTFLOW system (Model SFIP 2000) and related pulse transmission coefficient tools. These devices are designed for coronary and peripheral vascular assessments, providing real-time pressure data for diagnostic and interventional procedures.
The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Smartflow, Model Sfip 2000 Ref K003122
Regimes: 510(k) Registry: 510(k)Smartflow Pulse Transmission Coefficient Ref K020127
Regimes: 510(k) Registry: 510(k)Smartflow Ref K012947
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Florence Medical, Ltd. have in the registry?
The registry currently lists 3 devices for Florence Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Florence Medical, Ltd.'s devices?
Among its 3 most recently registered devices, Florence Medical, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Florence Medical, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Florence Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Florence Medical, Ltd. in the registry?
The most recently registered devices listed for Florence Medical, Ltd. include SMARTFLOW, MODEL SFIP 2000, SMARTFLOW PULSE TRANSMISSION COEFFICIENT and SMARTFLOW.