Product code NVP

Device name

Holding Chambers, Direct Patient Interface

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.5630

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

Source

FDA openFDA device classification dataset