← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K925587

# NASAL/ORAL MASK (K925587)

_Respironics, Inc. · BZD · Sep 14, 1993 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K925587

## Device Facts

- **Applicant:** Respironics, Inc.
- **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md)
- **Decision Date:** Sep 14, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5905
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K925587](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K925587)

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