Product code QNZ

Device name

Powered Communication System For Emergency Use

Medical specialty

Unknown

Device class

N

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency.

Source

FDA openFDA device classification dataset