510(k) K101532
K101532 is an FDA 510(k) premarket notification submitted by Pharmacaribe for the device "NESSI OTC SPACER". The FDA issued a decision of Substantially Equivalent on September 1, 2010. The device falls under product code NVO (Spacer, Direct Patient Interface), a Class II device regulated under 21 CFR 868.5630. Pharmacaribe has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2010
- Date Received
- June 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spacer, Direct Patient Interface
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
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.