Nessi Spacer
FDA 510(k) K091862 · Pharmacaribe
510(k) numberK091862
Submission
- Device name
- Nessi Spacer
- Applicant
- Pharmacaribe
Bonita Springs, FL, US - Received
- June 23, 2009
- Decision date
- November 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVO – Spacer, Direct Patient Interface
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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.
Other 510(k)s with product code NVO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101532 | Nessi OTC SpacerNVO · Traditional | Pharmacaribe | 09/01/2010SE |
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Questions and answers
When was Nessi Spacer cleared by the FDA?
Nessi Spacer (K091862) received a 510(k) decision of Substantially Equivalent on November 20, 2009, 150 days after the submission was received.
What is the product code of K091862?
The FDA product code is NVO – Spacer, Direct Patient Interface, a Class II (moderate risk) device regulated under 21 CFR 868.5630.