← Product Code [BYF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF) · K812066

# PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (K812066)

_Airlife, Inc. · BYF · Aug 3, 1981 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K812066

## Device Facts

- **Applicant:** Airlife, Inc.
- **Product Code:** [BYF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF.md)
- **Decision Date:** Aug 3, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5600
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K812066](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYF/K812066)

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