← Product Code [BYG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG) · K760329

# MASK, DISPOSABLE OXYGEN THERAPY (K760329)

_Inhal-O-Tech Medical Plastic · BYG · Sep 30, 1976 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K760329

## Device Facts

- **Applicant:** Inhal-O-Tech Medical Plastic
- **Product Code:** [BYG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG.md)
- **Decision Date:** Sep 30, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5580
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K760329](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K760329)

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