Product code QWX

Device name

Active Noise Attenuation System For Infant Incubators

Medical specialty

General Hospital

Device class

2

Regulation number

880.5405

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset