Product code QXQ

Device name

Respiratory Accessory Microbial Reduction Device.

Medical specialty

General Hospital

Device class

2

Regulation number

880.6993

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions.

Source

FDA openFDA device classification dataset