NVP · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5630
Classification
FDA Product Code
NVP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5630
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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