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Spacer, Direct Patient Interface

FDA product code NVO · 2 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5630
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-11-20 – 2010-09-01

Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles.

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