QWX — Active Noise Attenuation System For Infant Incubators Class II

FDA Device Classification

Classification Details

Product Code
QWX
Device Class
Class II
Regulation Number
880.5405
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN220048invictus medicalNeoasisJune 16, 2023