Bionaire Corp.
CanadaFDA applicant, unverified
- Devices
- 2
What Bionaire Corp. makes
Bionaire Corp. manufactures air purifiers and ionizers, including HEPA-filtered models designed to remove airborne particles and allergens. Their product line includes standalone air cleaners like the Clear Air Air Purifier & Ionizer and HEPA purifiers such as the SH-1240, SH-1260, SH-1840, SH-1860, and CH-3550 series.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Bionaire Clear Air Air Purifier & Ionizer Ref K942434
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionaire Corp. have in the registry?
The registry currently lists 2 devices for Bionaire Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionaire Corp.'s devices?
Among its 2 most recently registered devices, Bionaire Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bionaire Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bionaire Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionaire Corp. in the registry?
The most recently registered devices listed for Bionaire Corp. include BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER and BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550.