Spaulding Clinical Research, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Spaulding Clinical Research, LLC makes
Spaulding Clinical Research, LLC manufactures electrocardiograph devices, including the Spaulding Electrocardiograph 2100iQ and the SPAULDING IQ ELECTROCARDIOGRAPH. These devices are designed for cardiac monitoring and recording electrical activity of the heart, supporting clinical diagnostics.
The company’s electrocardiograph portfolio is classified under FDA Class II devices and is listed via 510(k) clearance. The devices are regulated under US FDA standards and are based in the United States.
Catalogue
Spaulding Electrocardiograph 2100iQ Ref K150564
Regimes: 510(k) Registry: 510(k)Spaulding Iq Electrocardiograph Ref K110065
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spaulding Clinical Research, LLC have in the registry?
The registry currently lists 2 devices for Spaulding Clinical Research, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spaulding Clinical Research, LLC's devices?
Among its 2 most recently registered devices, Spaulding Clinical Research, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Spaulding Clinical Research, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spaulding Clinical Research, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spaulding Clinical Research, LLC in the registry?
The most recently registered devices listed for Spaulding Clinical Research, LLC include Spaulding Electrocardiograph 2100iQ and SPAULDING IQ ELECTROCARDIOGRAPH.