NVO · Spacer, Direct Patient Interface
Anesthesiology · 21 CFR 868.5630 · Class 2
Overview
| Product Code | NVO |
|---|---|
| Device Name | Spacer, Direct Patient Interface |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101532 | NESSI OTC SPACER | Pharmacaribe | Sep 1, 2010 | SESE |
| K091862 | NESSI SPACER | Pharmacaribe | Nov 20, 2009 | SESE |
Top Applicants
- Pharmacaribe — 2 clearances
