# Resuscitator, Manual, Non Self-Inflating
> **Product code: NHK** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5905
## Classification
- **FDA Product Code:** NHK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.5905
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NHK)
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