Xhale, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Xhale, Inc. makes
Xhale, Inc. manufactures the Assurance Alar, a nasal SpO2 sensor designed for continuous oxygen saturation monitoring, and the Nasal SpO2 Sensor, a standalone device for pulse oximetry readings.
The company’s products are regulated as Class II medical devices in the US and are listed under the FDA’s 510(k) premarket notification process. The devices are based in the United States.
Catalogue
Nasal Alar SpO2 Sensor Ref K171423
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Assurance Alar / Nasal SpO2 Sensor Ref K143216
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xhale, Inc. have in the registry?
The registry currently lists 3 devices for Xhale, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xhale, Inc.'s devices?
Among its 3 most recently registered devices, Xhale, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Xhale, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Xhale, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xhale, Inc. in the registry?
The most recently registered devices listed for Xhale, Inc. include Nasal Alar SpO2 Sensor, ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 and Assurance Alar / Nasal SpO2 Sensor.