Good Sleep CO Pte, Ltd.
SingaporeFDA applicant, unverified
- Devices
- 3
What Good Sleep CO Pte, Ltd. makes
Good Sleep CO Pte, Ltd. manufactures sleep monitoring devices, including the Hushd Pro Avera, Hushd Avera, and Hushd Pro Z-Link. These products are designed for continuous respiratory and sleep pattern assessment, often used in pediatric and adult sleep studies.
The company’s devices fall under FDA Class II regulation and are listed via the 510(k) pathway. They are based in the United States.
Catalogue
Hushd Pro Avera Ref K232025
Regimes: 510(k) Registry: 510(k)Hushd Avera Ref K252161
Regimes: 510(k) Registry: 510(k)Hushd Pro Z-Link Ref K251784
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Good Sleep CO Pte, Ltd. have in the registry?
The registry currently lists 3 devices for Good Sleep CO Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Good Sleep CO Pte, Ltd.'s devices?
Among its 3 most recently registered devices, Good Sleep CO Pte, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Good Sleep CO Pte, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Good Sleep CO Pte, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Good Sleep CO Pte, Ltd. in the registry?
The most recently registered devices listed for Good Sleep CO Pte, Ltd. include Hushd Pro Avera, Hushd Avera and Hushd Pro Z-Link.