Engstrom Medical
Country not established
- Devices
- 2
What Engstrom Medical makes
Engstrom Medical manufactures disposable medical devices, including flexible tubing and heat and moisture exchangers (HMEs)/filters designed for single-use in respiratory and ventilation applications.
These products are classified as Class I devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Disposable Flex Tube Ref K954197
Regimes: 510(k) Registry: 510(k)Disposable Hme/Filter Ref K954194
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Engstrom Medical have in the registry?
The registry currently lists 2 devices for Engstrom Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Engstrom Medical's devices?
Among its 2 most recently registered devices, Engstrom Medical has devices listed in FDA 510(k) (2 devices).
What risk classes do Engstrom Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Engstrom Medical's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Engstrom Medical in the registry?
The most recently registered devices listed for Engstrom Medical include DISPOSABLE FLEX TUBE and DISPOSABLE HME/FILTER.