← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K002001

# BREEZE SLEEPGEAR WITH DREAMSEAL (K002001)

_Puritan Bennett Corp. · BZD · Sep 6, 2000 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K002001

## Device Facts

- **Applicant:** Puritan Bennett Corp.
- **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md)
- **Decision Date:** Sep 6, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **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/K002001](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K002001)

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