Healkee Medical Pte, Ltd.
SingaporeFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Healkee Medical Pte, Ltd. makes
Healkee Medical Pte, Ltd. manufactures the AirKEE P900 and AirKEE T900, which are portable respiratory devices designed for continuous positive airway pressure (CPAP) therapy.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
AirKEE P900 Ref K232933
Regimes: 510(k) Registry: 510(k)AirKEE T900 Ref K232642
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Healkee Medical Pte. Ltd. Singapore North West · SG FEI 3044735899
Frequently asked questions
How many devices does Healkee Medical Pte, Ltd. have in the registry?
The registry currently lists 2 devices for Healkee Medical Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healkee Medical Pte, Ltd.'s devices?
Among its 2 most recently registered devices, Healkee Medical Pte, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Healkee Medical Pte, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Healkee Medical Pte, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healkee Medical Pte, Ltd. in the registry?
The most recently registered devices listed for Healkee Medical Pte, Ltd. include AirKEE P900 and AirKEE T900.
Which FDA establishments are linked to Healkee Medical Pte, Ltd.?
1 FDA establishment is linked to Healkee Medical Pte, Ltd. in the registry; they are listed on the company page.