← Product Code [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) · K944347

# PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR) (K944347)

_Puritan Bennett Corp. · BTM · Dec 12, 1994 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K944347

## Device Facts

- **Applicant:** Puritan Bennett Corp.
- **Product Code:** [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM.md)
- **Decision Date:** Dec 12, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5915
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K944347](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K944347)

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