← Product Code [KGB](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB) · K883766

# MOUTH-TO-MASK VENTILATORY ADJUNCT (K883766)

_Medic One · KGB · Oct 21, 1988 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K883766

## Device Facts

- **Applicant:** Medic One
- **Product Code:** [KGB](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB.md)
- **Decision Date:** Oct 21, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5570
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K883766](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KGB/K883766)

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