C Change Surgical, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What C Change Surgical, LLC makes
C Change Surgical, LLC manufactures intraoperative fluid warmers, including the INTRATEMP Solution Warmer and the C Change Solution Warmer, designed to maintain or raise the temperature of intravenous fluids during surgical procedures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Intratemp Solution Warmer Ref K083417
510(k) 510(k)C Change Solution Warmer Ref K051819
510(k) 510(k)
Frequently asked questions
How many devices does C Change Surgical, LLC have in the registry?
The registry currently lists 2 devices for C Change Surgical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list C Change Surgical, LLC's devices?
Among its 2 most recently registered devices, C Change Surgical, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do C Change Surgical, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for C Change Surgical, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from C Change Surgical, LLC in the registry?
The most recently registered devices listed for C Change Surgical, LLC include INTRATEMP SOLUTION WARMER and C CHANGE SOLUTION WARMER.