# Isocapnic Ventilation Device
> **Product code: QFB** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 868.5480
## Classification
- **FDA Product Code:** QFB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.5480
- **Review panel:** AN
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QFB)
---
*AI Analytics · CC0 1.0*