Healthhub
South KoreaFDA applicant, unverified
- Devices
- 1
What Healthhub makes
Healthhub manufactures the HPACS, a medical device designed for patient monitoring and acute care support in hospital settings. This system integrates physiological data collection, automated alerts for critical parameters, and connectivity with electronic health records to assist clinical decision-making.
The HPACS is classified as a Class II device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States, where its device portfolio is registered and overseen by the FDA.
Catalogue
Hpacs Ref K250039
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthhub have in the registry?
The registry currently lists 1 device for Healthhub. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthhub's devices?
Among its 1 most recently registered device, Healthhub has devices listed in FDA 510(k) (1 device).
What risk classes do Healthhub's devices fall under?
Among its 1 most recently registered device, the classes recorded for Healthhub's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthhub in the registry?
The most recently registered devices listed for Healthhub include HPACS.