Clement Clarke Intl., Ltd.
United KingdomFDA applicant, unverified FDA FEI 3002806708
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Clement Clarke Intl., Ltd. makes
Clement Clarke International produces respiratory diagnostic devices, including peak flowmeters (such as the AirZone and VM Plus), spirometry systems (ONEFlow FVC and its variants), and inspiratory flowmeters (In-Check). The company also manufactures ophthalmic imaging systems, such as the EyeCap Imaging System, for eye examinations.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Eyecap Imaging System Ref K000368
Regimes: 510(k) Registry: 510(k)Airzone Peak Flowmeter Ref K982334
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
In-Check Inspiratory Flowmeter Ref K980960
Regimes: 510(k) Registry: 510(k)Mini-Wright Digital, Model 3120001 Ref K053156
Regimes: 510(k) Registry: 510(k)Vm Plus Peak Flowmeter Ref K962074
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002806708
- Address
- Cynon Valley, Mountain Ash Rhondda Cynon Taff
Frequently asked questions
How many devices does Clement Clarke Intl., Ltd. have in the registry?
The registry currently lists 6 devices for Clement Clarke Intl., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clement Clarke Intl., Ltd.'s devices?
Among its 6 most recently registered devices, Clement Clarke Intl., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Clement Clarke Intl., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Clement Clarke Intl., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clement Clarke Intl., Ltd. in the registry?
The most recently registered devices listed for Clement Clarke Intl., Ltd. include EYECAP IMAGING SYSTEM, AIRZONE PEAK FLOWMETER, ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN and IN-CHECK INSPIRATORY FLOWMETER.