DeviceClearance

Product code QWX— General Hospital

Neoasis

Classification name
Active Noise Attenuation System For Infant Incubators
Device class
Class 2
Regulation
21 CFR 880.5405
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.”

— U.S. Food and Drug Administration, device classification record for product code QWX under 21 CFR 880.5405, via openFDA

Market context for product code QWX

FDA has cleared 1 device under product code QWX, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWX

Recent clearances under product code QWX

Data sourced from openFDA. This site is unofficial and independent of the FDA.