Sky Innovation Technology ( Shanghai) Limited
ChinaFDA applicant, unverified
- Devices
- 1
What Sky Innovation Technology ( Shanghai) Limited makes
Sky Innovation Technology (Shanghai) Limited manufactures the XM-01, an electronic automatic blood pressure monitor designed for clinical and home use. The device measures systolic and diastolic blood pressure and pulse rate, providing digital readings for patient monitoring.
The XM-01 is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sky Innovation Technology ( Shanghai) Limited have in the registry?
The registry currently lists 1 device for Sky Innovation Technology ( Shanghai) Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sky Innovation Technology ( Shanghai) Limited's devices?
Among its 1 most recently registered device, Sky Innovation Technology ( Shanghai) Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Sky Innovation Technology ( Shanghai) Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sky Innovation Technology ( Shanghai) Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sky Innovation Technology ( Shanghai) Limited in the registry?
The most recently registered devices listed for Sky Innovation Technology ( Shanghai) Limited include XM-01 Electronic Automatic Blood Pressure Monitor.