510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVOClass II

Spacer, Direct Patient Interface

21 CFR 868.5630 / Anesthesiology
FDA source (opens on fda.gov)

NVO is the FDA product code for Spacer, Direct Patient Interface, a class II device type, regulated under 21 CFR 868.5630. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NVO
Device name
Spacer, Direct Patient Interface
FDA definition
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.
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NVO

By decision year
2 clearances under product code NVO with a decision year between 2009 and 2010, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NVO by decision year
YearClearances
20091
20101

Applicants with the most clearances

Product code NVO
Applicants holding the most 510(k) clearances under product code NVO
ApplicantClearances
Pharmacaribe LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code