← Product Code [BTL](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL) · K895946

# BIVONA CARDEN INTERMITTENT JETTING DEVICE (K895946)

_Bivona Medical Technologies · BTL · Jan 9, 1990 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K895946

## Device Facts

- **Applicant:** Bivona Medical Technologies
- **Product Code:** [BTL](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL.md)
- **Decision Date:** Jan 9, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5925
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A powered emergency ventilator is a demand valve or inhalator 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/BTL/K895946](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTL/K895946)

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