Aspen Medical, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Aspen Medical, Ltd. makes
Aspen Medical, Ltd. manufactures the PHOENIX 5 Urodynamics System, a diagnostic device used for evaluating lower urinary tract function by measuring bladder pressure and flow dynamics during filling and voiding phases.
The company’s portfolio is regulated under Class II devices in the US, with the PHOENIX 5 Urodynamics System authorised via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Phoenix 5 Urodynamics System Ref K914300
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aspen Medical, Ltd. have in the registry?
The registry currently lists 1 device for Aspen Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aspen Medical, Ltd.'s devices?
Among its 1 most recently registered device, Aspen Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Aspen Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Aspen Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aspen Medical, Ltd. in the registry?
The most recently registered devices listed for Aspen Medical, Ltd. include PHOENIX 5 URODYNAMICS SYSTEM.