NVO · Class II · 21 CFR 868.5630

FDA Product Code NVO: Spacer, Direct Patient Interface

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.

Leading manufacturers include Pharmacaribe.

Total

Cleared

120d

Avg days

2009

Since

FDA 510(k) Cleared Spacer, Direct Patient Interface Devices (Product Code NVO)

2 devices

1–2 of 2

Anesthesiology · 150d

About Product Code NVO - Regulatory Context

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Data Source

FDA 510(k) public files . 176,325 total devices indexed.

Latest clearance: Sep 01, 2010

Product Code Info

Code	NVO
Device class	Class II
CFR	21 CFR 868.5630
Panel	Anesthesiology

Verify on FDA.gov

View NVO classification on FDA.gov →