Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 3
What Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. makes
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. manufactures non-invasive patient monitoring devices, including fingertip pulse oximeters for oxygen saturation measurement, automatic arm electronic blood pressure monitors, and infrared forehead thermometers (models LFR30B, LFR50, LFR60). These devices are designed for clinical and home use to track vital signs such as blood pressure, heart rate, and body temperature.
The company’s products fall under FDA Class II regulatory classification and are listed via the 510(k) pathway in the United States. The devices are intended for use in medical settings and consumer environments, adhering to U.S. regulatory requirements for non-invasive diagnostic tools.
Catalogue
Fingertip pulse oximeter Ref K202776
Regimes: 510(k) Registry: 510(k)Automatic Arm Electronic Blood Pressure Monitor Ref K210435
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. have in the registry?
The registry currently lists 3 devices for Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.'s devices?
Among its 3 most recently registered devices, Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. include Fingertip pulse oximeter, Automatic Arm Electronic Blood Pressure Monitor and Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60.