← Product Code [BYE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE) · K953485

# SIMS CPAP SYSTEM (K953485)

_Smiths Industries Medical Systems, Inc. · BYE · Oct 26, 1995 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K953485

## Device Facts

- **Applicant:** Smiths Industries Medical Systems, Inc.
- **Product Code:** [BYE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE.md)
- **Decision Date:** Oct 26, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5965
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K953485](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYE/K953485)

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