← Product Code [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) · K944301

# HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 (K944301)

_Hudson Respiratory Care, Inc. · BTM · Dec 21, 1994 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K944301

## Device Facts

- **Applicant:** Hudson Respiratory Care, Inc.
- **Product Code:** [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM.md)
- **Decision Date:** Dec 21, 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/K944301](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K944301)

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