Oakfield Instruments, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 8
What Oakfield Instruments, Ltd. makes
Oakfield Instruments, Ltd. manufactures cardiac imaging and monitoring devices, including nuclear cardiology systems like the SOURCERER and CARDIOSCINT (Left Ventricular Function Monitor) for diagnostic imaging, as well as ambulatory pH monitoring systems such as the FLEXILOG series (1010, 2000, 3000, and LS variants) for gastrointestinal studies.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These devices are intended for use in the United States, where Oakfield Instruments is based.
Catalogue
Sourcerer Ref K894902
Regimes: 510(k) Registry: 510(k)Cardioscint (Left Ventricular Function Monitor) Ref K902460
Regimes: 510(k) Registry: 510(k)Mediscint Ref K920115
Regimes: 510(k) Registry: 510(k)Flexilog Ls 13921 Ref K961895
Regimes: 510(k) Registry: 510(k)Flexilog Ls Ref K964804
Regimes: 510(k) Registry: 510(k)Flexilog 2000 Ref K945069
Regimes: 510(k) Registry: 510(k)Flexilog 1010 Ambulatory Ph Monitoring System Ref K896288
Regimes: 510(k) Registry: 510(k)Flexilog 3000 Ref K964589
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oakfield Instruments, Ltd. have in the registry?
The registry currently lists 8 devices for Oakfield Instruments, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oakfield Instruments, Ltd.'s devices?
Among its 8 most recently registered devices, Oakfield Instruments, Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Oakfield Instruments, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Oakfield Instruments, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oakfield Instruments, Ltd. in the registry?
The most recently registered devices listed for Oakfield Instruments, Ltd. include SOURCERER, CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR), MEDISCINT and FLEXILOG LS 13921.