# Ventilator-Compatible Nebulizer
> **Product code: SFP** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5630
## Classification
- **FDA Product Code:** SFP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.5630
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The device is intended to deliver nebulized medications through a ventilator breathing circuit.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SFP)
---
*AI Analytics · CC0 1.0*