Medical Device Manufacturer · CA , Lachine, Quebec

Bionaire Corp. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1994

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bionaire Corp. General Hospital ✕

2 devices

1-2 of 2

Cleared Dec 14, 1994

BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER

General Hospital · 208d

Cleared Nov 28, 1994

BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550

General Hospital · 174d