Product code NVO

Device name: Spacer, 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: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K101532	NESSI OTC SPACER	Pharmacaribe	2010-09-01
K091862	NESSI SPACER	Pharmacaribe	2009-11-20

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00709078008566	Earmates	WESTMED, INC.	2020-06-02
10709078008563	Earmates	WESTMED, INC.	2020-06-02
00709078002717	Microspacer, Bulk	WESTMED, INC.	2017-02-20
10709078002714	Microspacer, Bulk	WESTMED, INC.	2017-02-20

Related 510(k) Records#