# Mechanical Ventilator
> **Product code: ONZ** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5895
## Classification
- **FDA Product Code:** ONZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.5895
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable  of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ONZ)
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